ISO 13485 & EU MDR - Expert Advice Community

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  • Complaints handling and corrective actions

    Does a formal CAPA is always needed when complaints investigation results with corrective action task? or can it be included as part of the complaint activity and follow up? also if CAPA was assigned, can Complaint be closed?
  • Method for recording inspection activities

    We are looking at ways to reduce workload. One topic brought up was the recording of dimensional measurement. Some of the senior employees have mentioned that at previous companies they've worked at, they did not record dimensions at Incoming Inspection. Rather, after the completion of dimensional activities, a checkbox was checked that said something like "All dimensions were found to be within tolerance". This was sufficient for the auditors at those companies.
  • Paper-based or electronic records?

    What is the best practice with regards to records management? Do you suggest paper-based (physical) or electronic records? For now, I only have electronic records. Do you suggest we create physical records in addition?
  • Report writing for certification

    I would like to get an explanation of the report writing for this certification. Whether it is in international practice or has its own set of requirements requires two auditors, one viewing the scope of the quality management system and other one for the technical scope (by the technical expert). Is it provided by two auditors or is it just an auditor?
  • Electronic signature for ISO 13485 documentation

    Can you provide guidance on electronic signatures? Is there any special requirements or can we use a simple adobe sign for signing off on procedures etc for compliance?
  • Medical device file structure

    I was looking for the Medical device file structure, which is needed for ISO 13485 and CE. Can you help me with some template for that?
  • Is there a way to customize intake forms when filling out a customer complaint?

    Is there a way to customize the intake forms when filling out a customer complaint?
  • Is there checklist for ISO 13485 document requirements specifically for a 3PL?

    I was curious if there is a matrix or checklist of ISO 13485 document requirements specifically for a 3PL that will be storing and shipping inventory? No manufacturing or development activities will take place.
  • Customer complaints

    Is there a way to customize the intake forms when filling out a customer complaint?
  • Which of Compliance modules in Conformio are required by the ISO 13485&14971?

    Which of Compliance modules in Conformio are required by the ISO 13485&14971?
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