Guest
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
Assign topic to the user
Expert
Kristina Zvonar Brkić
Sep 10, 2020
Here you can find the general list of mandatory documents for ISO 13485:2016:
- List of mandatory documents required by ISO 13485:2016 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/
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:
- IEC 62304:2006/AMD 1:2015 Medical device software — Software life cycle processes — Amendment 1 https://www.iso.org/standard/64686.html
For more information on ISO 13485, please see the following links:
- What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
- Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
Comment as guest or Sign in
Sep 10, 2020
Sep 10, 2020
Sep 10, 2020