Google Analystics

Tuesday, 19 February 2019

Does ISO 13485 imply that a medical device is proven effective?

I received the following question from someone who viewed my video What is ISO 13485 for medical devices?

If a product has ISO 13485 certification, it means the product is of high quality, trustworthy, and reliable enough to be used as a medical device in any hospital / medical setting - correct?

Does it also imply that its performance or effectiveness is proven too?

Here is my reply...

Remember, it is the organisation, not the product, that is certified. Once the organisation is certified, all product should be manufactured following due process according to the quality management system as laid out in the Quality Manual.

For me, if a medical device manufacturer does not have ISO 13485 certification then they do not warrant a second look. ISO 13485 should be the first requirement for supplier qualification, but certainly NOT the only requirement.

Having ISO 13485 merely gets a manufacturer to first base. It is not a home run. The customer needs to do due diligence to ensure the medical device truly meets all requirements that are critical to quality for their use including, if appropriate, satisfactorily passing a supplier (2nd party) audit.