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Documented checklist for SaMD

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Guest user Created:   Sep 10, 2020 Last commented:   Sep 10, 2020

Documented checklist for SaMD

I have started worked with software base medical device company , i have to implement ISO 13485 for SaMD and i am new for software base medical device work , can you help me for documented checklist for SaMD

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 10, 2020

Here you can find  the general list of mandatory documents for ISO 13485:2016:

As a manufacturer of software, from that list you do not need the following:

  • Arrangements for control of contaminated or potentially contaminated product (clause 6.4.2)
  • Requirements for cleanliness of product (clause 7.5.2)
  • Records of sterilization process (clause 7.5.5
  • Procedure and records for validation of process for sterilization and sterile barriers systems (clause 7.5.7)
  • Records of traceability and name and address of the shipping package consignee (clause 7.5.9.2)
  • Procedure for preserving the conformity of product (clause 7.5.11)
  • Records of rework (clause 8.3.4)

If you do not have any kind of service (repair) in your business, then even the following requirement is not applicable for you:

  • Procedure and records for servicing of the medical device (clause 7.5.4)

Furthermore, each medical device software must be in compliance with the following standard:

For more information on ISO 13485, please see the following links:

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Sep 10, 2020

Sep 10, 2020