ISO 13485 is the globally recognized standard for Quality Management Systems (QMS) in the medical device industry. Compliance with EN ISO 13485 provides presumption of conformity with QMS requirements under EU MDR and IVDR and aligns directly with FDA's Quality Management System Regulation (QMSR).
End-to-End ISO 13485 Support
- Pragmatic QMS Implementation: Right-sized procedures and templates that fit your engineering culture without unnecessary bureaucracy.
- Design Control & Risk Integration: Seamless linkage between ISO 13485, ISO 14971 risk management, and IEC 62304 software lifecycle processes.
- Internal & Supplier Audits: Certified Lead Auditors identifying gaps early before certification and surveillance audits.
- Training & Capability Building: Practical workshops equipping R&D and leadership teams to operate the QMS confidently.
Get in touch with Glaze Medical to build or optimize your ISO 13485 QMS.