Documented checklist for SaMD

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/