The latest news and updates from cognidox

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...

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What Is cGxP?

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

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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...

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Post Market Surveillance for Medical Devices; Why, How & Who?

Post Market Surveillance (PMS) has been elevated in importance by the new MDR and IVDR regulations which will ...

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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...

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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...

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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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