The latest news and updates from cognidox

Joe Byrne

Recent Posts

How a QMS supports medical device risk management in ISO 13485

 

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How can you get your FDA 510(k) submission right first time?

  Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on...

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Automotive chip shortages: Why chip shortages mean opportunities for fabless semiconductor companies

  The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless...

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Why not use greenlight guru as your med tech eQMS?

Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...

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7 risks you run migrating to a med dev eQMS and how to manage them

Migrating to a new eQMS is a big step for any medical device company, with many pitfalls for the unwary. What ...

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Chips with everything? Could you win big in the RISC-V revolution?

The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...

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What is a document control system and why is it important?

Having a document control system in place is a requirement of quality standards and regulations around the wor...

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Cognidox rolls out new training analytics and project cloning features in v10.2

    Cambridge, UK, 3 May 2022: Cognidox, a leading provider of document management solutions for the high-tech...

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DHF, DMR and DHR. Demystifying FDA medical device development requirements

DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...

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Quality Control VS Quality Assurance. What is the difference?

QC is about detecting defects in your finished product, while QA is about preventing the defects from occurrin...

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What's a Device Master Record (DMR)? What’s the best way to compile it?

  The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and mai...

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Implementing Medical Device Design Controls for ISO 13485 and FDA 21 CFR 820

30 years ago the FDA introduced robust new requirements for medical device design control following a string o...

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Why not just use SharePoint for your Medical Device QMS?

A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...

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8 powerful benefits of a document management system

A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...

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What is an Electronic Document Management System (EDMS)?

An Electronic Document Management System (EDMS) is a software that centrally stores and organises documentatio...

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Is it possible? Lean Document control procedures in the life science sector

In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...

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4 ways to build an ISO 13485 compliant medical device QMS

Are you looking for ways to build and maintain the most efficient, ISO 13485 compliant QMS as your company con...

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10 reasons fabless semiconductor companies need a document control system

With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...

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What's the difference between a QMS, eQMS and an eDMS?

There are different ways companies can build required quality management systems, from using traditional paper...

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Why not just use Dropbox for your Medical Device QMS?

DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...

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11 'must have' features of medical device document control software

Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...

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Are you in control? Document lifecycle management software for ISO 9001 compliance

ISO 9001 requires you to control the document lifecycle to improve the efficiency and effectiveness of your bu...

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What’s the cost of chaos in a document management system?

Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...

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Why not just use Google Drive for your medical device QMS?

A Quality Management System is a requirement for medical device developers across the globe. But should you bu...

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Moving from paper to a digital medical device Quality Management System

The case for ditching paper-based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...

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What is 21 CFR Part 11? FDA requirements explained

WTH is FDA 21 CFR Part 11? That’s a question many medical device developers wanting to access the US market mu...

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Why not just use Google Drive as a Document Management System?

Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...

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QMS documentation requirements in ISO 13485

  How should you structure your documentation to meet the requirements of ISO 13485?

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What is document life cycle management & why does it matter?

What are the 7 stages of the document lifecycle?  Why is managing and controlling the lifecycle a critical par...

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Corrective actions: why, when and how?

It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...

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Document control in your medical device Quality Management System

Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...

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How to stop ‘over-processing’ in your medical device QMS

Building a quality management system is never a quick and simple process. But in medical device development, w...

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What is a UK Responsible Person (according to the MHRA)?

Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...

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7 Quality Management Principles of ISO 9001:2015 and how to live by them

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

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4 steps to build a simple & effective supplier quality management system

Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...

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Document Control requirements in ISO 9001:2015; what you need to know

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...

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How to develop a medical device; the 5 phases of med-tech development

The medical device development process is typically broken down into five distinct phases.  Each one requires ...

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What is document control?

How much control do you have over the documents your business generates? How much do you need?

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Life after Covid-19 for the IVD (in vitro diagnostics) industry

The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...

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EU IVDR (In Vitro Diagnostics Regulation): Time’s running out to comply

The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...

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8 GMP principles for med tech developers to live by

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

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What's the best document control software for ISO 9001 & ISO 13485?

There’s plenty of document management and file-sharing software available on the market, but not all of it is ...

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What are the FDA's requirements for CAPA (Corrective and Preventive Action)

Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...

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A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements

How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...

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Why your QMS needs to be an eQMS

If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...

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Compiling a design & development plan for your medical device

What are the planning requirements for a medical device design and development process? And what tools can hel...

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12 issues with virtual team collaboration tools that you should worry about

As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...

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Pros and cons of a phase gate process in new product development

Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...

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Can product innovation happen by accident?

Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...

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How are lean principles embodied in a good DMS?

Does your Document Management System (DMS) apply the five Lean principles to the way you work?

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7 reasons your business process modelling project is doomed

Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...

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Managing the change control process for GxP compliance

Change control in life science development is critical to ensuring the ultimate safety of end users. And havin...

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How secure is your virtual collaboration process?

Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...

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Preparing for ISO 9001 audits in a virtual world

For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...

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Process verification vs process validation for medical devices

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

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Is that final? 5 reasons to use document version control software

We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...

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Supporting product innovation with document control software

In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...

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Remote collaboration; risk or opportunity for new product development?

Remote collaboration is the new normal and set to be a major feature of the post-Covid world.  Workers have fo...

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6 questions to help you choose a med-tech eQMS

Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If...

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Cognidox v10.1 delivers new features for FDA compliance

Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...

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Electronic VS Digital Signatures? What do you need for a med-tech eQMS?

Would your business benefit from using electronic signatures within your digital quality management system (eQ...

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Precious Cargo: Covid-19 Vaccines and Good Distribution Practice (GDP)

The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...

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9 ways QMS software helps you maintain & demonstrate GxP compliance

Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...

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Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

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Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

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Knowledge or noise? Managing your company’s structured & unstructured data

Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...

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The 5 Pillars of GMP in the Pharmaceutical Sector

For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...

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QSR Compliance: What’s inside FDA 21 CFR Part 820?

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

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Why document review is critical to successful new product development

Inadequate document review is often to blame for failure in new product development and manufacturing processe...

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GMP v cGMP. What's the difference?

GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...

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Medical device audits: what, when, how and who?

Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...

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How Lean Documentation Creates Customer Value In The Development Cycle

In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...

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8 Tips For Documenting SOPs (Standard Operating Procedures)

There are many reasons why an organisation might need to document their SOPs. From training staff and identify...

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How to Ruin a New Product Development Process

It’s much easier to screw up a new product development process than mastermind a successful one.  Here’s how.

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What Is cGxP?

cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...

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Are Life Science Companies The New ‘Wildcatters’?

Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...

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Post Market Surveillance for Medical Devices; Why, How & Who?

Post Market Surveillance (PMS) has been elevated in importance by the new MDR and IVDR regulations which will ...

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An A -Z of Medical Device Development; Acronyms, Regulatory & Technical Terms

The regulations and literature surrounding medical device development are packed with acronyms and technical t...

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9 Ways Innovative Companies Use Their Document Management Software

The outlook for many companies might be unpredictable at the moment, but access to the right document manageme...

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Another Successful Exit For Another Cognidox Client

The US human interface company, Snyaptics Inc announced this week that they are acquiring DisplayLink Corp in ...

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8 Reasons To Document Your Standard Operating Procedures (SOP)

Documenting your SOP (standard operating procedures) can be a drag. It can feel unnecessary for a relatively s...

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Good Distribution Practices (GDP) In the Pharmaceutical Industry

Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...

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The 5 Stages of Document Control Vital For Effective NPD

There are five stages of document control critical to NPD and product management. If you have the digital tool...

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UltraSoC - another “Made in Cambridge” success story

Last week, news broke that Siemens is acquiring the Cambridge based company and Cognidox client, UltraSoC, in ...

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Will ISO certification give you a competitive edge?

The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...

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What are the IVDR and MDR requirements for Economic Operators

There are four entities defined under the EU MDR and IVDR as “economic operators”. Under the regulation, these...

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Cognidox gain ISO 9001:2015 and ISO 27001:2013 certifications

Cambridge, UK, 22 May 2020: Cognidox, a leading provider of document management solutions for the high-tech, m...

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What are the 7 stages of a new product development process?

A brief internet search will confidently tell you that there are anywhere between 4 and 8 stages of the ‘ideal...

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Digital Signatures: New MHRA guide clarifies remote approval requirements

A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...

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CBD, GMP and GdocP; quality management in the cannabis industry

Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....

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Compiling a Design History File (DHF) for a medical device product

For medical device developers assembling and presenting all the required documentation for the DHF (Design His...

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Remote collaboration in the age of Covid-19

One of the things Covid-19 has shown us, is that the digital agility of an organisation can mean the differenc...

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Why a file sharing app is not a document management system

There are many file sharing apps on the market right now. They range from ‘free’ or ‘low cost’ one size fits a...

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From NPD to NPI. Agility and control with a stage gate process

Developing a robust stage gate process is a vital part of many new product development (NPD) and introduction ...

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Why corrective action management goes wrong

ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...

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8 essential success drivers in a new product development process

For most high tech companies, developing profitable new products is their entire reason for being. 

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What's new for medical device manufacturers in iso 14971:2019?

The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...

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Looking the wrong way: 7 reasons Document Management Systems fail

Many organisations still operate without a central, shared Document Management System (DMS) that effectively m...

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Announcing the release of Cognidox v10

Cognidox’s commitment to improving usability and cross platform accessibility continues with the release of v1...

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The trick to a painless new product introduction process

Managing an NPI process can be fraught with difficulty as each new initiative brings with it the potential for...

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What is effective CAPA management?

Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an a...

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The New Year Honours Debacle: A document management disaster

We’ve all been there, haven’t we? We’ve all accidentally published online the addresses of hundreds of celebri...

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Made in cambridge: our part in a high tech product development success story

Cognidox’s story is bound up with that of the "Cambridge Phenomenon" the so-called Silicon Fen high-tech clust...

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What do you really need for successful medical device development?

There’s no shortage of words in print and online written by regulators, consultants and software developers ab...

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Organisational knowledge requirements in iso 9001:2015

The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...

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Med Tech: where to start - Product development or document management?

What should come first in a med tech project? Product development or documentation? 

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Compliance Vs. Kaizen; how quality management can be part of your DNA

Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...

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9 ways to screw up your business process mapping

Companies are often spurred to undertake business process mapping to improve their quality management.

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What kind of Product Management Process do you need?

How do you need your product management process to function? A classic article in the HBR got us thinking abou...

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What are good documentation practices & how can they best be implemented?

Good documentation practices (also known as GdocP or GDP) are standards for document management and control th...

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MDSW, IVDR, MDR and the new guidance from the EU

As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...

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GAMP 5 ®: How to take a risk-based approach to GP computerised systems

The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...

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ISO 27001 and ISO 9001: How an integrated response can work

Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...

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NASA & the bra makers; quality management in the space race

In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...

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What does a good change control process look like?

A change control process is a vital part of any product development and management function. But if it’s not e...

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ISO 26262: How can DMS solutions support the development of driverless tech?

Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...

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5 critical success factors for a new product development process

A responsive new product development (NPD) process has always been a key part of a high tech business strategy...

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How's your Quality Management - Ad hoc, analytical or chaordic?

  How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effectiv...

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Can a Stage Gate Process ever be agile?

Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...

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Choosing the best business management software for your company

Not all business management software solutions are created equal. They come in different shapes and sizes, wit...

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Riding the wave of the med-tech quality management challenge

Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...

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9 ways an Extranet Can Improve your Product Release Process

  Issuing a tech product release or a software update can be a challenging process. Handled badly it can resul...

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New IVD regulation is coming. are you ready?

From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...

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Google Drive Vs Dropbox as Document Management Systems

Google Drive and Dropbox are two of the most popular cloud-based, file-sharing platforms on the market today. ...

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EU Medical Device Regulations are changing. How and why?

From 2020 and 2022, EU Medical Device Regulations will change. This brings certain products into regulatory sc...

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Seven document control pitfalls and how to avoid them

Do your systems give you the kind of control over your documentation which really match the organisational, co...

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How to avoid the med tech graveyard with user centred design

A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...

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Why not just use Google Team Drive as a Document Management System?

Google Team Drive is a service which has been available by default to Business, Enterprise and Education G-Sui...

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Quality Management Vs Compliance.  What's the difference?

For many companies, compliance is, at best, regarded as a necessary evil, and at worst a never-ending ordeal. ...

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How a Document Management System can help you fight hyperscale threats

There is always commercial pressure on product developers to find better and more efficient ways to collaborat...

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The evolution of a Quality Management System

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...

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Box Vs Dropbox as Document Management Systems

Both Box and Dropbox Business are cloud-based file sharing solutions intended to give their customers the free...

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What investors need to know about your Product Management Process

Founders of companies are often, by necessity, their own Product Managers. They’re often the ones who have mos...

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7 Deadly Sins of the Product Development Process

OK, we admit it, there are definitely more than 7 deadly sins of the product development process. In fact, the...

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Why design controls matter in Medical Device Development

  When it comes to medical device development, the absence of comprehensive design and development documentati...

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Why not just use Box as a document management system?

Box is a popular cloud-based, file sharing solution, designed for use by enterprises to store business documen...

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Supply Chain Disruption and the Future of Trust

With a supply chain ripe for digital disruption, high tech manufacturing companies must evolve new ways of man...

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Prince2 and Document Control

Document control is a crucial part of any project management process. In this blog post we ask how the right D...

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3 Product Development Fails that cost a fortune (and a space craft)

We all make mistakes, but when a product development process fails it can have far-reaching financial and comp...

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7 tips for designing an effective Business Process Map

Business Process Maps are a key part of any Company Management System. They are the flow diagrams that help yo...

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5 Reasons to Invest in a Company Management System

There are many competing demands on the attention and resources of a growing business, but investing in the ri...

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Are you developing a medical device?

Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...

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ONEDRIVE VS SHAREPOINT AS DOCUMENT MANAGEMENT SYSTEMS

What is the best document management solution for you and your business, One Drive for Business or SharePoint?...

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Why the FDA want Proactive Quality Management Systems

Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...

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How to Build a QMS Your Team Will Actually want to Use

One of the main challenges of implementing a Quality Management System (QMS) is ensuring it is actually used f...

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4 sure signs you need to start Business Process Mapping

Business Process Mapping could be the first step you take towards creating a more efficient, profitable and qu...

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Why not just use Dropbox as a document management system?

Dropbox is an easy to use cloud storage and sync application that is increasingly used in work settings for fi...

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All You Really Need For Xmas is a Competitive Advantage

 As we approach the end of 2018 with all its political and economic earthquakes, how can your high tech compan...

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Why your Business Management System should be graphical

Adopting a Business Management System (BMS) is a well-established way to manage and control all the processes ...

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4 ways to fix a failing product development process with an agile tool-kit

A failing product development process can cost your sanity, your company’s reputation, and a lot of money. In ...

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Visualising Risk-Based Thinking in a Quality Management System

 If you’ve been focused on improving your company’s Quality Management System it’s likely you will have encoun...

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Late again? How to conquer the biggest challenge in product development

Delays are the biggest challenge for any product development cycle, they annoy clients, they sap the creative ...

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No more mavericks: Better QA through collaboration

It’s a cliche that good collaboration and teamwork maximises productivity. But in the high tech product develo...

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Is your QMS just for ISO certification?

 Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really...

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ISO 13485:2016 - decoding the enigma

Developing medical devices can be a process fraught with challenges. As a startup or established business abou...

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Burning money in the product development process? Don’t get wasted

Are you wasting money in a messy product development process? Are you constantly losing sight of your prioriti...

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5 ways Business Process Modeling can transform your company

For companies in the high tech sector, where time is precious and resources costly, a single mistake can be ve...

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Why not just use SharePoint as a Document Management System?

What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system for a growing b...

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How digital signatures can help secure regulatory compliance

Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...

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The product management challenge - when, who and how

The early stages of any start-up are critical to the overall success of the business. In product development, ...

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Tame the Product Development Cycle with a Lean DMS

In the white heat of the product development cycle there is always the potential for chaos. And high tech busi...

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How a DMS helps you get the most out of external collaborators

Good collaboration is at the heart of business success. And with the vast array of digital tools available to ...

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Effective product development with phase-gate control and a DMS

One of the hallmarks of innovative organisations is that they are very good at developing ideas into successfu...

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Successful exits with cognidox

At a time of innovation and increasing traction in IoT, the recent acquisition of S3 Semiconductors by Adesto ...

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6 ways to improve product release management

Most high tech companies have multiple products. And most products combine different project deliverables - ha...

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Is your information safe? Document security in the information age

Most people think of document security only in relation to highly sensitive documents. However, the security o...

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Are your ISO inspections painful? How to make your QMS really useful

Many quality managers find that as an ISO audit approaches, their stress levels increase. Are all the procedur...

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Improving product development productivity with DMS version control

Raising your productivity levels can improve your delivery to customers and your profitability. Productivity i...

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How to evaluate a document management system

A document management system (DMS) can measurably improve your productivity and efficiency. A good DMS helps m...

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7 questions to ask before choosing your DMS provider

If you’re new to document management systems (DMS), how do you know what to look for when choosing the right p...

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How a document management system contributes to a lean business model

Lean is a philosophy, a theory that acts as a guiding principle for continuous improvement and customer focus ...

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