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Tag: "Product: ISO 13485 Documentation Toolkit" - Expert Advice Community



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  • Filling documents

    1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

    2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

  • Inquiry for missed document

    My company was recently adopting your ISO 13485 system. Could you please check if the documents we get from you complied with MDSAP with the USA, Canada, Japan, Brazil, Australia and Europe (MDR) involved?
  • Mandatory documents for SaMD to develop QMS

    I have a question for you, and want to ask for your opinion. We are an  AI software team in a *** hospital. Our product is similar to ***. Our pneumothorax algorithm could automatically identifies findings suggestive of Pneumothorax based on chest X-ray scans and outputs an alert. Because this product is a pure software, i.e. SaMD(Software and medical device), we do not manufacture physical medical equipment and don't have some activities. For example, there is no sterilization activity in our production processes. I would like to know what documents are mandatory for a SaMD to develop a QMS? Looking forward to hearing from you
  • 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?
  • What to exclude from Procedures and/or Quality Manual?

    We will be NOT be designing or making medical devices. We will be molding plastic components that do not require sterilization. What should we exclude from our Procedures and/or Quality Manual?

  • Change controls

    I was wondering if you can help me with this question. This is regarding change controls specifically for changes to the quality system procedures such as SOPs and Work Instructions. How would these changes be initiated, reviewed and approved? I noticed there was not a change control form for this and I thought there would have been one in the Procedure for Document and Record Control.

  • Documents required by MDSAP and FDA in ISO 13485 Documentation Toolkit

    1. Do you have in your 13485 & MDR package documents required by MDSAP? If no, where I can get them. 2. The same question about your 13485 & MDR package documents required by FDA?"
  • Difference between list of internal documents and list of type of records

    Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records?