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Need your help to tell me is there a guideline on the oxygen tank?calibration?
Which area of ISO 13485 covers or fits the Clinical Evaluation part? Is it only in "7.3.7 Design and development validation"?
Are Cardiovascular Stent covered in ISO 13485?
What is the difference between an EU manufacturer's distributor and a (transport) service provider? Does the distributor have to do the installation too?
HI, I'm trying to find out if I need a calibration SOP for Design Controls. Since V&V are part of Design Controls, I would think that a calibration SOP has to be in place to ensure that a verification or validation is valid when using equipment that requires calibration. Any thoughts?.
Can a product owner who does not own ISO13485 but manufacturer has its ISO13485 apply and obtain CE marking for medical device product"
We will be working with importers / distributors for our product. Possibly we will be importer or distributor ourselves for some products in future.
When checking MDR obligations for economic operators they should (amongst other obligations) perform a verification of medical devices they handle.
I have clear what needs to be documented for the verification but what I do not have clear is whether this verification obligation applies
I highly appreciate your help, best regards,
Need to understand the requirements for a company providing technical services, including technical writing, for a medical device company.
Can I know which clause should I refer for supplier qualification?
for ISO 13485: 2016 - Is it 7.4.2 (c)?