The latest news and updates from cognidox

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...

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Process verification vs process validation for medical devices

Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...

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Bionic pigs are not enough. How to win med-tech investment if you're not Elon Musk

When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...

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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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