The latest news and updates from cognidox

Joe Byrne

Recent Posts

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...

Read More

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...

Read More

4 ways to build a medical device quality management system

Are you facing an urgent need to build a Quality Management System (QMS) for your medical device? Do you need ...

Read More

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 ...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

12 issues with virtual team collaboration tools that should worry you

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

Read More