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Medical Device Risk Management: ISO 13485 and ISO 14971 Compliance

ISO 14971:2019 defines the international requirements of risk management systems for medical devices. How does...

8 min read

Biotech Startup Companies: How to Take on the Pharma Giants and Win

Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund s...

5 min read

Navigating UKCA Marking for Medical Devices: What You Need to Know

Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and w...

5 min read

Understanding FDA 21 CFR Part 11: A Guide for Life Science Developers

WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...

5 min read

10 Steps for Seamless EQMS Data Migration

Transferring data to a new electronic Quality Management System (eQMS) can seem like a daunting prospect. Here...

3 min read

What happened at CogniCon24?

On the 16th of May, Cognidox welcomed nearly 100 attendees from across the high-tech, medical device, and phar...

3 min read

5 Steps to a Robust Corrective Action Process

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

6 min read

5 Challenges in Building a Pharmacovigilance System Master File

Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...

5 min read

The Importance of Document Control Systems in Business Operations

What does it mean to 'control documents'? And who needs a formal document control system to manage and optimis...

6 min read

Ultimate Guide to Deviation Management in Pharma & Bioscience

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

Enhancing Document Management: Why Google Drive Falls Short

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

5 min read

Mastering ICH Q8 R2: A Guide to Pharma Excellence

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

4 min read

Mastering Non-Conformance Reports: A Guide for Quality Management

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

Making the Switch: Transforming Your TMF into an eTMF

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

4 min read

The Vital Role of ALCOA Principles in Data Integrity for Life Sciences

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

5 min read

Navigating ISO 13485: 8 Key Clauses for Medical Device QMS Excellence

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

Moving from Paper to Digital: Overcoming QMS Challenges

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

4 min read

Understanding 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

Comparing eQMS Solutions: 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

Equipment Validation in Life Sciences: A Comprehensive Guide

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

5 min read

Demystifying Medical Device Audits: Requirements, Process, and Impact

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

Effective GxP Compliance: Managing Change Control for Safety

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

4 min read

The Importance of Flexible eQMS in Semiconductor Success

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

4 min read

Managing Clinical Trials: Meet GCP Guidelines with Cognidox

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

4 min read

FDA Regulation Update: QMSR and ISO 13485:2016 Explained

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

5 min read

Streamlining Medical Device Design Transfer: Key Steps for Success

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

3 min read

8 Tips for Effective SOP Documentation

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

4 min read

Document Control Software for ISO 9001 & ISO 13485: A Guide

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

4 min read

Quality Management Maturity Grid: A Roadmap to Excellence

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

3 min read

Mastering Medical Device Development: An A-Z Guide of Acronyms

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

9 min read

The Pros and Cons of Phase Gate Processes 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

Is SharePoint the Right Choice 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

Evolving Quality Management: From Ad Hoc to Chaordic

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

4 min read

7 Key Considerations Before Using Dropbox for Document Management

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

5 min read

Demystifying FDA 21 CFR Part 820: A Comprehensive Guide

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

5 min read

5 Phases of Developing Medical Devices: A Comprehensive Guide

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

5 min read

Building Your Digital QMS: Is Microsoft Software the Right Choice?

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

5 min read

The Importance of Equipment Calibration 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

Understanding Document Control in ISO 9001:2015

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

4 min read

4 Steps to Effective Supplier Quality Management

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

6 min read

Is Sharepoint 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

Understanding the Differences: ISO 9001 vs ISO 13485

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

4 min read

Understanding Post-Market Surveillance for Medical Devices in the EU

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 Streamlining Your 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

5 Reasons Why You Need 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

Understanding Medical Device Classification: MD, IVD, AIMD, or SaMD?

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

FDA CAPA Requirements: Ensuring Compliance and Quality Control

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

4 min read

Understanding QMS, eQMS, and eDMS for Quality Management Success

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

The Evolution of Quality Management Systems: A Path to Business Growth

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

4 min read

The Importance of Design Controls in Medical Device Development

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

3 min read

Navigating FDA Approval: Understanding 510K vs PMA

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

4 min read

Is Qualio the Right Choice for 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

Best Practices for Good Documentation in Regulated Industries

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

Tips for a Successful FDA 510(k) Submission: Get It Right

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

4 min read

Navigating the Automotive Chip Shortage

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

The RISC-V Revolution: Winning Big in the Chip Innovation Era

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

Cognidox Unveils Exciting New Features in v10.2 Release

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

1 min read

Understanding FDA Medical Device Development Requirements: DHF, DMR, DHR

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

4 min read

Understanding Document Management vs Document Control

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: Understanding the Differences

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

4 min read

The Ultimate Guide to Building a Device Master Record (DMR)

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

4 min read

Streamlining Medical Device Design Controls for FDA and ISO Compliance

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

5 min read

8 Key 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

Understanding Electronic Document Management Systems (EDMS)

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

5 min read

Effective Lean Document Control in Life Science Sector

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

5 min read

Building an ISO 13485 Compliant QMS: 4 Effective Strategies

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 Document Control

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

6 min read

Is Dropbox Suitable 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 Essential Features of Medical Device Document Control Software

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

5 min read

Mastering Document Lifecycle Management 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

The Cost of Chaos in Document Management: A Financial Wake-Up Call

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

3 min read

Is Google Drive Suitable 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

Structure Your QMS Documentation for ISO 13485 Compliance

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

4 min read

Understanding the Importance of Document Lifecycle Management

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

5 min read

Why 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

Mastering Document Control in Your Medical Device QMS

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

5 min read

How to Prevent 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

Understanding the UK Responsible Person Requirement Post-Brexit

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

4 min read

Navigating IVD Device Regulations in the UK: Challenges for Developers

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

4 min read

Mastering ISO 9001:2015 Quality Principles - A Guide to Implementation

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

3 min read

Navigating the Post-Covid Landscape: The Future of the IVD Industry

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

4 min read

Navigating EU IVDR Compliance: Key Changes and Deadlines

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

3 min read

8 Essential GMP Principles for Med Tech Developers

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

4 min read

The Power of Design Reviews: Preventing Costly Mistakes

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

3 min read

The Importance of a Quality Strategy for Your Company

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

The Pros and Cons of Virtual Collaboration for Product Innovation

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

5 min read

7 Key FDA E-Signature Requirements for Medical Device Developers

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

4 min read

The Power of eQMS: Elevating Your Quality Management System

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

4 min read

12 Virtual Team Collaboration Tool Issues to Address

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

3 min read

The Art of Accidental Innovation: Tales of Discovery and Success

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

4 min read

Embodying Lean Principles in Your Document Management System

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

3 min read

7 Common Mistakes in Business Process Modelling Projects

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

3 min read

Securing Virtual Collaboration: Risks and Solutions

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

3 min read

Navigating Virtual ISO 9001 Audits: A Guide for Success

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

4 min read

Understanding Process Verification vs 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: The Key to Success

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

4 min read

Maximising Remote Collaboration 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 Key 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: New Features for FDA Compliance in Med Tech

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

2 min read

Understanding Electronic Signatures in Med-Tech eQMS

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

4 min read

Navigating the Challenges of Covid-19 Vaccine Distribution

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

3 min read

Knowledge Through Information Management in ISO 9001- part II

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 Enhances GxP Compliance in Med-Tech

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

2 min read

Building Operational Resilience with a Document Management System

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

3 min read

Knowledge Through Information Management in ISO 9001

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

4 min read

Navigating the Med-Tech Investment Landscape: 5 Tips for Success

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

Managing Structured & Unstructured Data: Knowledge or Noise?

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

4 min read

GMP Compliance: The 5 Pillars of Pharmaceutical Sector Quality

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

2 min read

The Importance of Document Review in New Product Development

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

3 min read

Understanding GMP vs cGMP in Life Science Manufacturing

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

3 min read

Maximising Customer Value Through Lean Documentation

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

4 min read

Avoid These Common Mistakes in 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

Understanding cGxP: Ensuring Quality in Life Science Industry

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

4 min read

Life Science Companies: The New 'Wildcatters' of Innovation

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 Utilise Document Management Software

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

4 min read

Success Story: Cognidox Client DisplayLink Acquired for $407M

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

2 min read

Ensuring Quality in Pharma Distribution: The Importance of GDP

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

3 min read

Mastering Document Control 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 Acquisition by Siemens: A Cambridge Success Story

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

2 min read

The Competitive Edge of ISO Certification: A Path to Success

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

5 min read

Understanding Economic Operators in EU MDR and IVDR

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

4 min read

Cognidox Achieves 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

7 Essential Stages of New Product Development: A Comprehensive Guide

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

3 min read

MHRA Guide: Remote Approval Requirements for Digital Signatures

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

4 min read

Quality Management in the CBD Industry: GMP and GdocP Explained

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

6 min read

A Guide to Compiling a DHF for Medical Device Development

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

4 min read

Bug Tracking vs Help Desk Software: Understanding the Key Differences

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

Navigating Remote Collaboration Challenges in the Covid-19 Era

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

3 min read

File Sharing vs. Document Management: Key Differences

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

Navigating NPD to NPI: The Power of Flexible Stage Gating

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

3 min read

Common Pitfalls in Corrective Action Management: How to Avoid Them

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

4 min read

8 Essential Drivers for Successful New Product Development

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

3 min read

Understanding Organisational 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

ISO 14971:2019 Update for Medical Device Manufacturers

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

4 min read

The Pitfalls of Document Management Systems: 7 Common Failures

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

3 min read

Discover the Exciting Features of Cognidox v10

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

2 min read

Streamlining Document Management in 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

Mastering the NPI Process: Key Factors for Success

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

4 min read

Mastering CAPA Management in the Medical Device Industry

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 Data Breach: A Lesson in Document Management

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

3 min read

Cognidox: The Cambridge Success Story in High-Tech Product Development

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

5 min read

Essential Steps 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

Unleashing Organisational Knowledge: ISO 9001:2015 Requirements

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

3 min read

Navigating Med Tech: Starting with Product Development or Documentation?

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

5 min read

Quality Management: Balancing Compliance and Kaizen

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

Navigating the Product Management Process: Finding the Right Fit

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

5 min read

Navigating MDSW, IVDR, and MDR: New EU Guidance Decoded

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

3 min read

GAMP 5®: 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

Integrating ISO 27001 and ISO 9001: A Guide for High-Tech Businesses

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

3 min read

Quality Management Lessons from NASA's Space Race

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

4 min read

Effective Change Control Process: Key Strategies for Success

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

3 min read

Unlocking the Potential of DMS for Driverless Tech Development

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

4 min read

5 Key Factors for Successful New Product Development

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

4 min read

Can Agile Tools Enhance Stage-Gate Processes?

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 Right 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

Navigating the Challenges of Med-Tech Quality Management

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

4 min read

Enhancing Product Releases with an Extranet: 9 Key Strategies

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

3 min read

Navigating FDA Interactions: 10 Tips for Regulatory Success

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

Preparing for the New IVD Regulation: Key Steps to Compliance

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

3 min read

Google Drive Vs Dropbox: Choosing the Best Document Management System

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

4 min read

New EU Medical Device Regulations: What You Need to Know

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

5 min read

Avoid These 7 Document Control Pitfalls for Business Success

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

3 min read

Navigating the Med Tech Graveyard: A User-Centred Approach to Design

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

5 min read

Enhancing Document Management with Google Team Drive

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: Understanding the Key Differences

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

3 min read

Maximising Collaboration with a Document Management System

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

3 min read

Box Vs Dropbox: A Comprehensive Comparison for DMS

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

4 min read

Investor Insights: Product Management Process for Growth

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 Product Development: A Guide to Avoiding Disaster

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

4 min read

Box vs SharePoint: Choosing the Right Document Management System

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

5 min read

Navigating Supply Chain Disruption: 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

Enhancing Prince2 with Document Management Software

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 Costly Product Development Fails: Lessons Learned

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 Effective Business Process Mapping

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 Why Your Business Needs 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

Choosing Between OneDrive and SharePoint for Document Management

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

4 min read

Closing the Scale-up Gap: Business Model Canvas Essentials

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

5 min read

The FDA's need for Quality Management in Medical Device Development

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

3 min read

Closing the Scale-up Process Gap: A Structured Approach

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

4 min read

Building an Effective QMS Your Team Will Love

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

3 min read

Closing the Process Gap: A Key Challenge 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 Signs You Need Business Process Mapping

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

4 min read

Securing a Competitive Advantage even in Uncertain Times

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

4 min read

The Power of Graphical Business Management Systems for SMEs

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

4 min read

4 Ways to Improve Agile Product Development with Document Management

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

3 min read

Unlocking the Power of Visualising Risk-Based Thinking

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

4 min read