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Biggest challenge when seeking EU MDR compliance
What is the biggest challenge when seeking compliance to the EU MDR? -
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.
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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?
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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?