ISO 13485:2016
Medical Devices Quality Management.
MedicalQuality
ISO 13485:2016 represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It emphasizes risk management and compliance with regulatory requirements.
Key Benefits
- Ensure quality and safety of medical devices.
- Meet regulatory requirements for medical device markets.
- Improve risk management and traceability.
- Enhance customer confidence in medical products.
Who Needs This?
Medical device manufacturers, designers, distributors, and organizations involved in the medical device supply chain.
* Compliance is often mandatory for government tenders and corporate supply chains.
Ready to get certified?
We provide full documentation and training support.