The latest news and updates from cognidox

What are the IVDR and MDR requirements for Economic Operators

There are now four entities defined under the EU MDR and IVDR as “economic operators”. Under the new regulatio...

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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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Compiling a Design History File (DHF) for a med tech product

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

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

The medical device development process is often broken down by experts into five distinct phases which all req...

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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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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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