Medical Devices Quality Management Systems (MD-QMS)
Stringent regulatory compliance for design, cleanroom production, and device sterilization.
Standard Scope & Purpose
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Strategic Commercial & Operational Benefits
High-Level Structure & Core Clauses
Design & Development Controls
Design verification, clinical evaluations, and design history files (DHF).
Production & Service Provision
Cleanroom contamination controls, sterile packaging, and device history records.
Frequently Asked Questions (Technical Secretariat)
Q:Does ISO 13485 automatically grant CE mark approval?
No, but an accredited ISO 13485 certificate is the mandatory prerequisite audit evidence requested by Notified Bodies before granting CE mark authorization.
Certification Scheme Profile
3-Year Cycle with extensive technical documentation review
Annual On-Site Technical Audit
- Diagnostic Reagents & In-Vitro Diagnostic (IVD) Test Kits
- Surgical Robotics, Orthopedic Implants & Active Implantables
- Sterile Consumables, PPE & Catheters
- Software as a Medical Device (SaMD)
Compliant with IAF MD5 Manday Assessment
Included Accreditation Deliverables:
- Accredited ISO 13485 Certificate
- MDR-Aligned Audit Report
- Sterile Process Assessment