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  • 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
     

  • Does ISO 13485 apply to clinical CRO?

    Does this ISO 13485 apply to clinical CRO?

    We will be in charge of phase II study on an MD and the sponsor requests the knowledge we have on this standard.

  • Where requirement comes from to monitor and or record temperature and humidity during calibrations?

    What I am attempting to figure out is where the requirement comes from to monitor and or record temperature and humidity during calibrations? Any information on this topic would be appreciated. 

  • Design master file

    Is it required by 13485, MDR that the design master file (or similar naming) has to have control numbers, revision, and signoff, or is a date and sign off on the document sufficient. I will be thankfull for any help.

  • Medical Device File

    I do have queries pertaining to implementation of ISO13485:2016.  

    In particular on top of my list is about the Medical Device File or MDF.  Read through some articles, forums, blogs but I think I better seek advice from experts like you on this topic. 

    Although the ISO standard explicitly stated major areas for compliance as per clause 4.2.3, sub-clauses (a) through (f). I am keen to know what exactly are the documented information that fall into these categories. 

    I greatly appreciate receiving feedback from you on this subject.  Looking forward to receiving your reply. 
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