We are currently using the templates to design our ISO 13485 processes, primarily to apply for CE under the MDR of our new medical device.
In the light of this, you could help me out with the following.
- We designed this medical device together with an engineer of a foreign medical device production facility, which is already ISO13485 compliant.
- The product will only be produced for us, with our name on it. Some sort of Own Brand Labelling (OBL), but not completely the same.
- Based on the relevant risk classification rules, we classified the medical device in risk class IIa.
- We will have full access to all information and data needed to construct the technical file.
- Are there any ISO13485 processes and records in the template kit that would not be necessary for CE purposes, or would all be necessary, taking into account risk class IIa?
- How would an auditor exactly assess the implementation and operating effectiveness of these processes? I would guess according to the corresponding records, but how do they assess whether all records are in place for all cases that a record had to be registered?