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A Guide to Deviation Management in the Pharma & Bioscience Sectors

Managing deviations from standard operational procedures is critical to product quality and regulatory complia...

6 min read

Announcing CogniCon 24 - save the date!

The Cognidox team is delighted to announce we will be hosting CogniCon 24 on 16 May 2024. This is a networking...

1 min read

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...

5 min read

Quality by Design: How to embrace ICH Q8 R2 for pharma excellence

ICH Q8 R2 are international guidelines for ensuring Quality by Design in pharmaceutical development. Here’s wh...

4 min read

A short guide to non-conformance reports; what, why and how

How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...

6 min read

What does it take to make your TMF an eTMF?

A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...

4 min read

Data integrity in life sciences: the vital role of ALCOA principles

Data integrity is central to the safe development and manufacturing of every life-science product on the marke...

5 min read

ISO 13485:2016: What does it take to meet medical device QMS requirements?

Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...

6 min read

Medical Device Technical File requirements: what you need to know

What is the medical device technical file? What should it contain and how should it be structured? And is it e...

6 min read

4 challenges you'll face moving from a paper based QMS to an eQMS

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

4 min read

What are the ICH Q10 Pharmaceutical Quality System guidelines?

In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...

5 min read

The eQMS low down: Qualio Vs Cognidox

Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...

4 min read

Design verification and design validation for medical device developers

In medical device development, two critical stages of the design process are often confused: design verificati...

6 min read

MDSAP 101: An Introduction to the Medical Device Single Audit Programme

What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...

3 min read

What’s the Cost of Quality? Can it really be free?

What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...

4 min read

IQ, OQ, PQ: what's needed for equipment validation in life sciences?

Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...

5 min read

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...

5 min read

Cognidox announces new e-signature integration with DocuSign

Cognidox are delighted to announce the release of our new DocuSign e-signature integration. The new plug in is...

2 min read

UKCA Marking for Medical Devices: what's going on?

Post-Brexit there has been some confusion about the future use of UKCA (UK Conformity Assessed) markings and w...

4 min read

Managing the change control process for GxP compliance

Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...

4 min read

Chip design: Why a flexible eQMS is essential for semiconductor success

Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...

4 min read

How to manage clinical trials and meet GCP guidelines with Cognidox

Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...

4 min read

QMSR and ISO 13485:2016: what’s in the new FDA regulation?

At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...

5 min read

How to execute a seamless medical device design transfer process

Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...

3 min read

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...

4 min read

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 ...

4 min read

Where are you on the Quality Management Maturity Grid?

Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...

3 min read

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...

9 min read

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...

5 min read

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 ...

4 min read

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 effective ...

4 min read

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...

5 min read

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...

5 min read

What are the 5 phases of medical device development?

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

5 min read

Corrective action: why, when and how?

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

6 min read

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 ...

5 min read

Calibration of equipment in ISO 13485 and ISO 9001

Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...

4 min read

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...

4 min read

How to build a supplier quality management system in 4 simple steps

How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...

6 min read

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 (DMS) for a gro...

5 min read

How is Software as a Medical device (SaMD) regulated by the FDA?

Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...

5 min read

ISO 9001 vs ISO 13485. What’s the difference?

ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...

4 min read

What is post-market surveillance for medical devices?

The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...

4 min read

8 Tips for Improving the Document Review Process

How is the quality of your document review process affecting the speed and efficiency of the way you do busine...

3 min read

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...

3 min read

MD, IVD, AIMD or SaMD? What is a medical device?

Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...

5 min read

What’s the plan? A seamless product realisation process for ISO 13485

So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...

4 min read

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...

4 min read

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...

5 min read

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...

5 min read

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...

5 min read

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...

4 min read

Why design controls matter in Medical Device Development

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

3 min read

The FDA submission process: 510K vs PMA. What’s the difference?

How can medical device developers gain FDA approval for their devices and permission to sell their product int...

4 min read

Why not just use Qualio as your medical device eQMS?

Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...

5 min read

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

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

4 min read

How to scale your medical device consultancy practice

Many medical device consultancy practices work on a fee-based model, helping clients with regulatory and quali...

4 min read

How a QMS supports medical device risk management in ISO 13485

A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...

4 min read

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 t...

4 min read

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

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

4 min read

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) ...

4 min read

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 ...

6 min read

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’...

4 min read

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...

6 min read

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, me...

1 min read

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...

4 min read

Document Management and Document Control: Is there a difference?

For some companies simply managing their documentation is enough to support their business goals. But others n...

4 min read

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...

4 min read

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 maint...

4 min read

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...

5 min read

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...

4 min read

What is an Electronic Document Management System (EDMS)?

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

5 min read

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...

5 min read

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...

4 min read

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...

6 min read

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...

5 min read

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

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

5 min read

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...

1 min read

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...

3 min read

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...

5 min read

QMS documentation requirements in ISO 13485

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

4 min read

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 part...

5 min read

Take it from me: your medical device start-up needs a Lean eQMS

In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...

5 min read

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...

5 min read

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...

4 min read

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 ...

4 min read

Understanding the regulation: challenges for UK IVD device developers

IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...

4 min read

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...

3 min read

What is document control?

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

4 min read

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...

4 min read

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...

3 min read

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...

4 min read

In praise of the Design Review Process

I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...

3 min read

Why your company should have a Quality Strategy

I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...

3 min read

11 myths about ISO 9001 - busted!

Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...

3 min read

Can Product Innovation Tools help you go 'virtual first?'

Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...

5 min read

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...

4 min read

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...

4 min read

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...

3 min read

Can product innovation happen by accident?

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

4 min read

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?

3 min read

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 ...

3 min read

How secure is your virtual collaboration process?

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

3 min read

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 ...

4 min read

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...

3 min read

Supporting product innovation with document control software

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

4 min read

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 fou...

4 min read

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...

3 min read

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...

2 min read

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...

5 min read

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...

3 min read

Organizing Organizational Knowledge: the case for information management in ISO 9001 (Part 2)

In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...

5 min read

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)...

2 min read

How a Document Management System can help build operational resilience

If you’re not planning to improve your operational resilience, you’ve not been paying attention. How can a dig...

3 min read

Organizing Organizational Knowledge: the case for information management in ISO 9001 (Part 1)

In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-mak...

4 min read

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 ...

3 min read

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...

4 min read

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...

2 min read

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...

3 min read

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...

3 min read

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...

4 min read

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.

5 min read

What Is cGxP?

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

4 min read

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...

4 min read

7 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...

4 min read

Another Successful Exit For Another Cognidox Client

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

2 min read

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...

3 min read

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...

4 min read

UltraSoC - another “Made in Cambridge” success story

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

2 min read

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 -...

5 min read

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...

4 min read

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...

3 min read

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...

4 min read

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...

4 min read

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....

6 min read

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...

4 min read

On the difference between Bug Tracking and Help Desk software

There's a long-running debate whether a bug or defect tracking software tool is just a synonym for a help or s...

3 min read

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...

3 min read

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...

4 min read

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 ...

3 min read

Why corrective action management goes wrong

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

4 min read

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.

3 min read

Organizational knowledge in ISO 9001:2015

One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...

2 min read

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...

4 min read

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...

3 min read

Announcing the release of Cognidox v10

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

2 min read

Document management for the Life Sciences industry

If you took a snapshot of document management around 20 years ago, the general situation was that in my indust...

4 min read

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...

4 min read

What is effective CAPA management?

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

4 min read

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...

3 min read

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...

5 min read

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...

5 min read

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...

3 min read

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

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

5 min read

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 ...

4 min read

9 ways to screw up your business process mapping

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

4 min read

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...

5 min read

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’...

3 min read

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...

4 min read

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...

3 min read

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 ...

4 min read

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...

3 min read

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...

4 min read

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...

4 min read

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...

3 min read

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...

4 min read

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...

4 min read

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 result ...

3 min read

How to talk to the FDA

I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...

2 min read

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...

3 min read

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. ...

4 min read

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...

5 min read

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...

3 min read

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...

5 min read

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...

4 min read

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. ...

3 min read

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...

3 min read

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...

4 min read

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...

4 min read

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...

4 min read

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...

5 min read

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...

3 min read

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...

3 min read

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...

3 min read

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...

3 min read

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...

3 min read

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?...

4 min read

The Scale-up Process Gap and the Business Model Canvas

In part one of this series we argued that one key ingredient for a successful scale-up company is optimisation...

5 min read

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 ...

3 min read

The Scale-up Process Gap - Getting Started

Our opening post on this theme introduced the problems that companies face as they transition from start-up to...

4 min read

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...

3 min read

The Process Gap for Scale-up companies

It seems everyone is talking about Scale-up companies these days. The term has been around since 2013 (see for...

5 min read

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...

4 min read

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 company...

4 min read

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 ...

4 min read

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 ...

3 min read

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 encount...

4 min read

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 ...

4 min read

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...

3 min read

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 ...

3 min read