QMS software for SaMD teams

Software as a medical device still needs a quality management system. The records are different from a hardware line. The clauses are not.

A SaMD team is often a handful of engineers, a part-time quality lead and a cloud release process. ISO 13485 still asks for controlled procedures, competence, purchased services (including cloud and development tools), complaint handling, and corrective action. IEC 62304 is the software lifecycle standard many files add on top. ISO 14971 is still the risk-management standard. HAVGATE does not implement 62304 work-item tracking or a hazard trace matrix. It implements the QMS records around them.

Use document control for the procedures: software lifecycle, problem resolution, release, complaint, and the change process that connects a software defect to a CAPA. Use training for the people who may release or who handle complaints. Use supplier quality for the cloud providers and the eQMS itself. Use the audit module to sample those processes, including MDSAP if you are in the program. Design and development of the software can be audited with MDSAP Chapter 5 tasks. The tickets and the code stay in your development tools.

Part 11 and computer software assurance matter twice: once for the device software and once for HAVGATE if you rely on it for required records. Those are different validations. The glossary pages on Part 11, CSA, and IQ/OQ/PQ are the short versions. The security page is the hosting statement for this product.

SaMD companies still send invoices and talk to clinics or partners. CRM and bookkeeping can live beside the QMS, separated so a release record is not a sales note. That is the platform idea. It is not a claim that HAVGATE is an ALM or a clinical EDC.