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Joe Byrne

Joe Byrne
Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

Recent Posts

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

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

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

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

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

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

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

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