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I was reading the full text of MDR, in this regard, if I have correctly understood: the technical file of the device is mandatory to be registered by an EU manufacturer or its representative. Once this is done in the EU country of the manufacturer or representative, the device can be put on the market in ALL EU countries (not only the country where it was registered). Am I right?
Can you apply your Project Checklist for ISO 13485:2016 Implementation in a food processing organization?
As I work through the course material it is becoming increasingly clear that as a small company like mine-my ability to act as an internal auditor may not be feasible as I cannot audit the processes I am involved in. I am also Purchaser and QMS Manager.
It would not be possible for another member of my team to audit purchasing processes as they are not qualified. We received a finding on a past audit as our Internal Audit was deemed unqualified.
Please advise how other small companies navigate this situation.
We are a manufacturer of cleaning chemicals, some of which are used in the medical industry, for cleaning medical devices, apparatus, equipment, etc.
We have always been led to believe that we needed to adhere to ISO 13485 however, upon reading the document, I am not sure that it applies to us. Can your expert provide further clarification please?
I am looking for information on labeling of medical device accessories. Specifically, we have a handpiece to improve delivery of laser energy from the fiber to the patient tissue. The notified body (under MDD) advised us to put the same laser safety labels on the handpiece (laser class, etc) as we already have on the laser itself. I cannot find any advise like this in the standards (IEC60601-1, IEC60601-2-22, IEC60825-1)
1: Do we need a Technical File for outsourced products that are manufactured elsewhere?
2: Do we need a Technical File for products that we relabel?
3: Do we need a Technical File for products that we do not adapt or manufacture ourselves but that we buy and resell (as part of one of our products)?
I need your support on an issue, we changed the contact sterilization supplier of our class I sterile product.
Is this significant change according to MDR article 120?
I need to do a decision tree evaluation on this,
I need information on this topic.