A Quality Management System (QMS) is the operational framework ensuring that every medical device or SaMD product consistently meets safety, quality, and regulatory standards such as ISO 13485 and EU MDR Article 10(9).
Pragmatic QMS Setup & Ongoing Operation
- Tailored Architecture: We build right-sized QMS structures that integrate naturally with modern R&D and agile software workflows rather than slowing teams down.
- Full Lifecycle Coverage: From Design Controls, risk management, and supplier oversight to release procedures, CAPA, and post-market vigilance.
- Training & Continuous Support: Hands-on onboarding, internal audits, and ongoing QA support so your QMS stays effective and audit-ready year after year.
Contact Glaze Medical to establish or streamline your medical device QMS.