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  • Procedure for Design documentation management for medical devices

    Do you have separate procedure for "Design documentation management for medical devices"?  I mean how to execute drawings, Bill of materials, schemes electrical and so on? Thanks

  • CE Mark

    We would like to inquire after regulations / requirements needed for a patient controlled analgesia pump. Is there a guideline that needs to be followed or adhered to in order to get the CE mark on a product?

  • Equipment Qualification vs. Process Qualification and Process Validation

    I am trying to get a better understanding about the guidance on Equipment Qualification vs. Process Qualification and Process Validation. Can you refer me to the sections of the standard that speak about those topics?

  • Medical devices

    Are medical devices subject to the falsified medicines directive (tamper proof and individual serialisation) or are you aware if this is the long term plan for them to meet this requirement?

  • Determining scope of certificate for company that outsources production processes

    How do you determine the scope of a certificate for a company that outsources production processes?

  • 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


    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?


  • 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?

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