shimonv
Trusted Information Resource
Hi Fellows,
A company that I work for has a class I medical device which is in commercial use for several years. They now need to make the adjustments for MDR.
One of the MDR requirements, which is my opinion is a waste of time, is a clinical evaluation report according to MEDDEV 2.7/1 revision 4. It's a big task which is usually outsourced and quite expensive.
Does anyone have ideas or experience on how to work around this? Perhaps some rationale / memo to file.
Thanks,
Shimon
A company that I work for has a class I medical device which is in commercial use for several years. They now need to make the adjustments for MDR.
One of the MDR requirements, which is my opinion is a waste of time, is a clinical evaluation report according to MEDDEV 2.7/1 revision 4. It's a big task which is usually outsourced and quite expensive.
Does anyone have ideas or experience on how to work around this? Perhaps some rationale / memo to file.
Thanks,
Shimon