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

Home / Product: ISO 13485 Documentation Toolkit

Discussions

Top Contributors

Expert

Rhand Leal

3377
Discussions
Expert

Carlos Pereira da Cruz

1799
Discussions
Expert

Dejan Kosutic

366
Discussions

Most Popular Tags

Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 Product: ISO 27001 Documentation Toolkit Risk Assessment ISMS Product: ISO 13485 Documentation Toolkit Internal Audit Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit Product: ISO 27001/Risk Assessment Table ISO 9001 BCMS Certification scope Product: EU GDPR & ISO 27001 Integrated Documentation Toolkit EU GDPR
Category:
Select
CREATE NEW TOPIC +
Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • 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?