The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
Inadequate document review is often to blame for failure in new product development and manufacturing processe...
GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...
There are many reasons why an organisation might need to document their SOPs. From training staff and identify...
It’s much easier to screw up a new product development process than mastermind a successful one. Here’s how.
cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...
Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...
