ISO 13485 Certification
ISO 13485 ensures quality and safety in medical device manufacturing, meeting stringent regulatory requirements worldwide.
Key Benefits:
- Ensures product safety
- Meets regulatory standards
- Enhances market access
Relevant Industries:
- Medical Devices
- Healthcare
- Pharmaceuticals
About ISO 13485 Certification
ISO 13485 is the global standard for Quality Management Systems in medical device manufacturing, ensuring product safety and regulatory compliance. It covers design, production, and distribution processes.
Omni Certification International (OMNI) guides you through ISO 13485 certification, from process assessment to implementation. This certification is essential for medical device and healthcare industries, enabling global market access and ensuring patient safety.