The latest news and updates from cognidox

Joe Byrne

Recent Posts

QSR Compliance: What’s inside FDA 21 CFR Part 820?

The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

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Why document review is critical to successful new product development

Inadequate document review is often to blame for failure in new product development and manufacturing processe...

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GMP v cGMP. What's the difference?

GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...

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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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How Lean Documentation Creates Customer Value In The Development Cycle

In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...

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7 Tips For Documenting SOPs (Standard Operating Procedures)

There are many reasons why an organisation might need to document their SOPs. From training staff and identify...

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How to Ruin a New Product Development Process

It’s much easier to screw up a new product development process than mastermind a successful one.  Here’s how.

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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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