ISO 13485 & EU MDR - Expert Advice Community

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  • Toolkit content

    I would like to ask about the documents included with the "ISO 13485 & MDR Integrated Documentation Toolkit toolkit with expert support" 
    We are a company with class I medical devices and are in the process of creating the SOPs to be compliant with MDR
    Are your SOPs geared towards medical devices with higher classes (therefore more detailed and technical) or are they also suitable / can be modified for class 1 devices
    For class 1 medical devices, we need to do SOPs for regulatory strategy; final product release; vigilance; and field safety corrective action. I don't seem to see those in the list of SOPs via the preview, and wanted to check if those are included or under a different name?

    Also, does your company provide a way to identify in the SOPs which part of the relevant SOP is necessary for Class 1, and which parts are not? As we will likely only want to include the necessary info and not give extra unnecessary info.

  • Are ISO 22716 and ISO 13845 comparable as certification scheme?

    I'm quality assurance and regulatory manager for a biotech company in Italy. We are going to do the ISO 9001, 14001 and 22716 standards the next june. I was wondering if 22716 and 13845 are comparable as certification scheme which are the difference between the two scheme?

  • Procedure for risk assessment

    Reading the template text 06 for risk assessment in the iso13485 documentation set, I wonder if this procedure is compliant with ISO 14971 (the text mainly refers to FMEA). If not, is there a template text that follows ISO14971?

  • 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?

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