ISO 13485 is a global recognized standard for Quality Management Systems (QMS) in the medical device industry. It sets out the requirements for a comprehensive QMS that ensures the safety and effectiveness of medical devices throughout their lifecycle. This standard provides a framework for medical device manufacturers and suppliers to demonstrate their commitment to quality, regulatory compliance, and customer satisfaction.

ISO 13485 certification offers several benefits for medical device manufacturers and suppliers, including:

1. Compliance with regulatory requirements: including the European Union Medical Device Regulation (EU MDR) and the U.S. Food and Drug Administration (FDA) regulations.
2. Improved product quality
3. Enhanced customer satisfaction
4. Increased efficiency and productivity

ISO 13485 includes several requirements for a QMS in the medical device industry, including:

1. Management responsibility
2. Resource management
3. Design and development
4. Purchasing and supplier management
5. Production and service provision
6. Monitoring and measurement
7. Continuous improvement

We help our clients to implement and maintain an effective QMS that meets ISO 13485 requirements and other relevant standards and regulations. We offer a range of services, including:

1. Gap analysis
2. Implementation support
3. Internal and External Audits
4. Regulatory compliance

Contact us today to learn more about how we can help you achieve ISO 13485 certification and improve the quality and safety of your medical devices.