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Stage 1 audit
What can a company expect from Stage 1 - 13485:2016 Auditor?
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Certification qualification
If a company does not existingly have a medical product in its production, does it qualify for certification?
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Calibration
have a question in relation to our external calibration .
I have started a new job and a new role in calibration .
my question is for years the company has had some of the equipment calibrated from an external company and as i was going through some of the calibration certs and i noticed that their reference equipment had a tolerance of +- 1.5 % rH and our equipment has a tolerance 3% rH. is this expectable for ISO13485 (this means a ration 2:1) -
udi for Legacy devices
We have 1 product group under CE MDD.(Legacy medical device)
This certificate is valid till end 2023.
Must we place new symbols/UDI codes acc. MDR on our labels after 26-05-21?
There are no expected changes to the product.
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Appendix for Design and Development
why, for example, the appendix for Design and Development are not all in one?
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Guideline on oxygen tank calibration
Need your help to tell me is there a guideline on the oxygen tank?calibration?
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Clinical Evaluation
Which area of ISO 13485 covers or fits the Clinical Evaluation part? Is it only in "7.3.7 Design and development validation"?
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Are Cardiovascular Stent covered in ISO 13485?
Are Cardiovascular Stent covered in ISO 13485?
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Difference between EU manufacturer's distributor and (transport) service provider
What is the difference between an EU manufacturer's distributor and a (transport) service provider? Does the distributor have to do the installation too?
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Calibration SOP
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?.