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  • Timeline for updating documents

    Our company has bought few Advisera documents regarding ISO 13485 risk management and clinical evaluation. Can I ask you a question I have been struggling to find the answer? How often should those documents be updated? Clinical evaluation plan and review; risk management plan, file, review? We are producing class I medical devices.

  • Question about records

    We are working on the procedure for Document and Record Control and some questions have come up. 

    Can you help explain what types of records need to be recorded?

    Do we need to list all the types of records and why would we need it? 

    Would a CAPA be a record or a document?

  • Reagent equivalency requirement

    Can you please direct me to a part in regulation on lab reagent equivalency requirement?
    I am involved in project to asses equivalencies of reagents used in lab but not entirely sure where to go for information on requirements for performing equivalency study of reagents for analytical test method

  • ISO 13485:2016 regulatory expectations around distributors

    What are the ISO 13485:2016 regulatory expectations around distributors?

    Around distributor qualification, management, customer complaints, supply or QA agreements,

  • Implementation duration

    I have a question for you. I am experienced with ISO9001 and 13485.  Conducted many audits as the company representative. I am working with a small startup site, no employees or equipment yet and am tasked with putting in a 13485 system in an ISO8 cleanroom operation. Using your toolkit and no employees, other than a few senior leadership individuals who will not help much, how long should I allocate to getting all the procedures in place to pass an audit?
  • Question about SaaMD

    Is your toolkit for MDR compliance optimized for software as a medical device?

  • Rework requirements

    Under what circumstances a medical device which has already been put into service can be returned by the user or patient to the manufacturer to be repaired or modified? Does this trigger any documentation or procedures to be in place? What are the risks?

  • MDR Labelling

    For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?  

  • Auditing and creating checklist for medical device labeling

    How to audit and create a checklist for medical device labeling including advertising and claims?

  • Most difficult issue and challenge during initial implementation

    What would be the most difficult issue and challenge during initial implementation?

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