Articles tagged with: Conformity assessment

The clear definition of useful life and its various interpretations for each type of device (active, software, single-use, implantable...)

A detailed analysis of the conditions that impose additional duties, beyond standard obligations, according to MDR.

The difference between placing on the market and making available, to clearly define when to adapt devices to MDR.

Quality system, technical file, and notified body. The details of how to obtain CE marking for a medical device.

Even Class I reusable surgical instruments must be evaluated by the notified body, according to MDR.