ISO 13485:2016.
Medical Devices Quality Management System
A comprehensive quality compliance standard for the design, production, and distribution of medical devices in accordance with strict medical industry regulations.
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Overview
ISO 13485 is a specific quality standard for medical devices. It regulates everything from design and production to distribution to comply with strict medical industry regulations.
Who it's for
Manufacturers, distributors, and suppliers of medical device components who must meet regulatory and customer requirements.
Service coverage
- Design control: control of product design and development.
- Risk management: application of risk approach throughout the product lifecycle.
- Controlled production: validation of processes and work environments.
- Traceability: lot recording and field corrective actions.
How it works
Submit an application, we review the scope, then auditors conduct stage 1 and stage 2 audits before an independent certification decision is made.
Benefits
- Fulfillment of medical device regulatory compliance.
- More guaranteed product quality.
- Opened local and international market opportunities.
Pricing & offers
Costs depend on the scope, number of locations, and number of employees. Contact us for a quote tailored to your organization.
Have questions about this service?
Discuss your needs with our team