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List of ISO Standards for medical devices and IVD’s
Is there a list available with all the ISO Standards for medical devices and IVD’s?
Mock recall in medical devices
I was looking for information regarding Mock recall in medical devices UK & EU under ISO 9001 & ISO 13485
Complying with ISO 14971
As part of the ISO 13485, do we also need to comply with ISO 14971?
Replacement for Directive 93/42/EEC
According to MDR 2017/745 - which kind of certification will replace Directive 93/42/EEC?
Training in the company

I would like to check with on actual process for Training in company.What are documents required and who will be the people responsible.
Symbol MD in the label of Medical Devices Class I (no sterile)
Hello, from today on, to be compliant with the new EU MDR, the production of Medical Devices Class I (non sterille), needs to have the MD symbol in the label? Thank you, Isabel Sottomayor
Standard for chlorine dioxide sterilization of medical devices

What standard to I require for chlorine dioxide sterilization of medical devices?
Question about requirements

We have extended our MDD and I have done a gap analysis according to CAMD Transition Sub Group
Specifically Section III.
But I'm now wondering are there other requirements that I'm missing?
Rework procedure

Is a rework procedure needed for ISO13485?
Test method validation

We have been certified recently. Nevertheless I still have some troubles with test method validation. It’s a very complex material.

Currently, I struggle to establish whether a validation has to be conducted on some benchmark or our product. The product of ours is being developed. Currently we found optimal conditions to conduct the trial of production process. Development of the product is promising so we’ve decided to validate a crucial process. Do you have any thoughts on that matter?