Medical Devices
ISO 13485 Certification
ISO 13485 is an international standard for Quality Management Systems (QMS) specific to the medical device industry. It ensures that medical devices meet regulatory requirements and are safe and effective for use.
At GSIC, we support organizations in achieving ISO 13485 certification by implementing tailored QMS practices, ensuring compliance and quality in medical device production.
- Ensures safety and efficacy of medical devices
- Supports compliance with global regulatory requirements
- Improves product quality and reliability
- Enhances market access and customer trust
- Streamlines manufacturing and quality processes