Post-Market QMS Toolkit for SaMD

For SaMD companies with a cleared or authorized device that are getting ready to sell. You already have a quality management system. This toolkit adds the procedures and forms you need once your product is on the market, numbered to fit with our Pre-Market QMS Toolkit.

The templates are built around ISO 13485:2016, which FDA's Quality Management System Regulation (21 CFR 820) incorporates by reference since February 2, 2026. The November 2026 update corrects which records FDA can inspect. Version 2.0, rebuilt for the QMSR, is planned for February 2027, and we will email buyers when it is ready.

Procedures (9 SOPs)

• SOP 0008 Contract Review
• SOP 0020 Interacting with the FDA
• SOP 0021 Conducting Recalls
• SOP 0022 Medical Device Reporting
• SOP 0023 Post-Market Surveillance
• SOP 0024 Control of Measurement Equipment
• SOP 0025 Customer Inquiries and Complaints
• SOP 0026 Technical Support
• SOP 0027 Internal Audits

Forms and logs (14)

• Complaints and support. Product inquiry and complaint form, inquiry and complaint log (Excel), technical support report
• Reporting and recalls. MDR determination form, health hazard evaluation, product recall worksheet, recall notification format, recall status report format
• Audits. Annual internal audit plan, internal audit schedule, audit attendance sheet, internal audit report
• Monitoring. Post-market schedule and summary, equipment calibration record

Also included

• Microsoft Word and Excel files you can edit
• Instructions and tips for each template in our online portal
• Access to updates, when applicable
• A 30-minute call with Cosm

The procedures are written for US FDA requirements. EU MDR documents such as PSURs and PMCF plans are not included.

Interested in a specific template only? Contact us at templates@cosmhq.com.

All templates are sold as-is, without any warranties or guarantees of functionality, compatibility, or fitness for a particular purpose. By purchasing, you acknowledge that modifications may be required to suit your specific needs. No refunds, exchanges, or customizations are provided. If you have any issues, feel free to reach out for general guidance, but support is not guaranteed