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  • MDSAP audit

    Our medical device is in the last phase of design and development.
    We are a start up medical device company in ***.

    1. What stage of completion do we have to be in to be ready for an MDSAP audit?

    2. Does our device need to be a finished device?

    3. Does our DMR need to be completed and do we have to have all our verification and validation plans and reports completed?

    Please let me know your thoughts on this.

  • IS IEC 62304 included in toolkit Advisera offers?

    Hi there. I have a question regarding your template for ISO 13485 & MDR documentation. We are an artificial intelligence medical software company that have to CE certify our first product. I read that - as a SaMD company - you also need to conform IEC 62304. Is this included in the toolkit Advisera offers?

  • Consequences of medical device company not following regulations

    "what are the consequences of a medical device company not following regulations?

  • Validation Procedure

    Does the pack include one and I just can't find it? Or is that something you provide separately or at all?

  • EU medical device regulation

    We are going to will start production of menstural tampons. This type of products are not medical device in EU and are clasified as medical device in USA and Canada. We are located in EU, but our target markets are EU and USA.
    Please advise if our manufacturing plant should be certified acc. ISO 13485 ?
    Thank you in advance

  • ISO 13485:2016 - Complaints Handling

    Hi. With ISO13485 is 'Complaints' only related to product? Customer complaints about service, late deliveries, wrong billing etc. Are they considered Complaints or Feedback?

  • Preparing site for first-time audit

    How to prepare the site for a first-time audit for ISO 13485?

  • Comparison from ISO 13485 to EU MDR

    I am specifically looking for a comparison from ISO13485 to EU MDR. Meaning e.g. 13485 clause 8.2.1 references (equal to) to MRD Article 83.

  • Can a medical device do self-calibration?

    Can a medical device do self-calibration or does it need another calibrating device to do the calibration?

  • MHRA & Med Devices RO requirement after Jan 1 2021

    hi, Kristina what services are you providing for the new regulations and Med device RP requirements post Brexit for imported Medical Devices? thanks
     
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