Neues von Lean RAQA Systems
How long have you been dating your Notified Body – “NB” for short? Is your eye beginning to wander?
It should wander if your NB won’t be able to support your business once the Medical Directive Regulation (MDR) takes hold.
If that’s the case, it may be time to ‘swipe left’ and get yourself in a new relationship.
Why do you care about regulatory change? Keeping pace with change generates cash flow. Your product gets to market faster and stays on the market longer. When you’re doing those things, you’re making money.
This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” (See the first installment and second installment.) This post explores examples and application provided within Practical Guide for the implementation of a “risk-based approach” along with color commentary from yours truly.
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.