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  • Team training in Good Manufacturing Practices - is it essential?

    Is it essential to keep the entire team trained in Good Manufacturing Practices?

  • Statistical techniques used while analyzing the data according to ISO 13485

    What are statistical techniques to be used while analyzing the data according to ISO 13485? Procedures shall include the determination of appropriate methods, including statistical techniques and the extent of their use.

  • ISO 13485 vs EN ISO 13485

    I need a detailed comparison of ISO 13485 to EN ISO 13485 to illustrate the technical requirements are the same.

  • ISO 13485 implementation

    1. As we are a low-risk class I one medical device manufacturer, if we want to declare our conformity according to MDR do we also need to comply with all the applicable harmonized standards like (ISO 13485, ISO 14971, IEC 60601-1-2) ? Or are these standards optional for class I?

    2. Do we need ISO 13485 or other certification from an accredited body? 

  • 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?
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