Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management

[funkgirl]

Has/does anyone use Hazard Analysis and Critical Control Point (HACCP) in their device risk management process? Do you use it for design, manufacturing, or both? How well is it accepted by regulatory authorities/auditors? What are the biggest benefits and challenges?

Thanks in advance...

 

[Ronen E]

As far as I know it's more related to the food industry.
I don't know any medical devices companies that use that approach to risk management (and I know a few).
Today the vast majority of medical devices manufacturers follow ISO 14971 or a variant of it. This is what most serious regulators expect.

 

[funkgirl]

True on its background, but HACCP is referenced as a tool in the current version of 14971, so I'm keen to see how it's applied in practice for devices...