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  • Good Manufacturing Practice in pharmaceutical

    We are looking for guidance with regards to Good Manufacturing Practice. Is this a certification that pharmaceutical companies need to apply for? How do they apply? If the company has ISO13485, can they use the GMP mark? or do they need to be registered for GMP?

  • Adverse Event Reporting

    Hello

    As a distributor of medical devices, if there is an adverse event, would I need to report it to the MHRA (we are UK based) or would that be the responsibility of the manufacturer?

    thanks 

  • Specific requirement to provide After-Sales Service

    I was wondering, according to MDSAP/ISO 13485 or Health Canada regulation, is there any specific requirement to provide After-Sales Service or spare parts for specific time (such as 10 years /20 years)?

  • Is technical file of device mandatory to put on device on market?

    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?

  • Applying Project Checklist for ISO 13485:2016 Implementation in a food processing organization

    Can you apply your Project Checklist for ISO 13485:2016 Implementation in a food processing organization?

  • Mandatory information in Conformity Declaration for Medical Device Class I

    Hello, I have a Conformity Declaration from a supplier for MD Class I non-sterile, under MDR 2017/745, that identifies the product with "name", "model" (uses the references of the products), "GMDN" and "Classification" (Class I). There is already a text field for "Basic UDI-DI", but is still empty. Recently I asked for a new product class I with a new reference, produced only for us. I asked for an update of the Conformity Declaration and the supplier told me the one I have is enough for the new reference because it is under the same "Name" and "GMDN". Is that correct? Doesn't the  MDR oblige to an "unambiguous reference allowing identification and traceability of the device", for this one in particular? Shouldn't the supplier add the new "Model"? Additionally, when will the Basic UDI-DI be mandatory in these declarations? Thank you, Isabel Sottomayor

  • ISO 13485 Internal Auditor

    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.

  • Do we need ISO 13485?

    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?

  • Labeling of medical device accessories

    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)

  • Questions regarding Technical files 13485/MDR

    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)?
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