ISO 13485:2016
Medical Devices Quality Management System
QMS standard specific to the design and manufacturing of medical devices
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 regulatory requirements.
Who Should Get Certified
- Intended for organizations involved in the lifecycle of medical devices:
- Medical device manufacturers
- Suppliers and subcontractors
- Packaging and sterilization companies
- Diagnostic laboratories
- Regulatory affairs consultants
Benefits of ISO 13485:2016 Certification
Ensures product safety and regulatory compliance
Reduces risk of product failures or recalls
Increases market access, especially in regulated regions
Improves process efficiency and quality consistency
Builds confidence with regulators and healthcare providers
Certification Process
- Application Submission
Organization provides scope of device lifecycle involvement. - Quote & Contracting
Based on company size, risk, and product type. - Stage 1 Audit – QMS Documentation Assessment
Evaluation of design controls, quality plans, and compliance policies. - Stage 2 Audit – Product & Process Evaluation
On-site verification of manufacturing, labeling, traceability, etc. - Certification Decision
Certification granted if compliance is confirmed. - Surveillance & Recertification Audits
Ongoing audits to ensure regulatory readiness.
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