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Validation of computer software is specified in section 4.1.6 of ISO 13485:2016. The main messages there are: ... add test procedures and acceptance criteria and go through the tests. For each test, document whether it was a Pass or Fail. Add screenshots if appropriate. Done! That was easy. I'll try to add a template with GitHub as an example ...

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The certified processes and procedures that we have implemented throughout the facility will help us prove our commitment to quality to our customers." ISO 13485:2016 is an internationally ...

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ISO 13485 Consultants: Gives you the methodology on how to implement MDMS Projects faster and easier than ever before. Experienced Medical Device Management Professionals : Understand the impact of the revised Standard, the 130+ instances where documentation may be required, and best practice in maintaining an MDMS.

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To consider with 13485:2016, examples • Monitoring and measurement (Sec 8) • Monitor if the organization has met customer requirements, methods to be documented • Procedures for post market feedback • Reporting to regulatory authorities. New section • Complaint handling. New section • Verify that the CA & PA actions does

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Use our free ISO 13485 procedure template and the list of ISO 13485:2016 mandatory procedures to build your Medical Device quality system and get certified. Cynamed Cyzr-0320 Heidbrink Root-Tip Picks,no.h2

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13485:2016 Requirement of the EN ISO 13485:2016 + AC:2016 MDD/MPG: Questions related to the requirements of the MDD 93/42/EEC (MPG, Germany, resp.). The numbering of the QM-Elements of DIN EN ISO 13485:2016 is used for the chapters. 2. Use of the Assessment Checklist

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