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  • ISO 13485 queries

    Among the questions I have during the implementation of the QMS there are the following:

    • The change control procedure does not seem to take in consideration the NBOG guidance or MDCG-13 or to advise the registrar.
    • Is there a tri-party quality agreement between sterilizer/contract manufacturer/ legal manufacturer?
    • Records retention seems always be for 2 or 5 years.  I couldn’t see anything for 10 years per MDR.
    • Statistical procedure seems to be missing.

  • Defining quality objectives

    Want to know about quality objectives. Do we need to define quality objectives every year? Department-specific quality objectives or product-specific?

  • Relation between Directive IVDR 98/79, IEC 64304, 62366 and ISO13485

    The relation between Directive IVDR 98/79, IEC 64304, 62366 and ISO13485. Esepecially the documentation.

  • Procedure for document and record control- the incoming mail register

    Please can you assit me. With regards to the Procedure for document and record control- the incoming mail register.. I do not see an appendix for this document? Must I create it? Also how necessary is this section if there is only the managing director of the company and no other employees?

  • Oximeter and Heart Rate Measurement

    What accuracy (in terms of %age) is required for device to get ISO certified? or what is the acceptable error range for readings?

  • 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.
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