Customer satisfaction and patient safety is driven by adhering to regulatory standards and complying with a quality management system (QMS). A QMS provides processes and accountability by which your company operates, and under which your product is developed, to ensure patient satisfaction and safety. We develop your product under our own certified QMS, and can work with you to create, understand, and use your own QMS as a driving factor of product success.
- ISO 9001 for customer focus and customer satisfaction quality
- ISO 13485 for patient focus of medical device development and safety
- IEC testing management
- Bench and Clinical testing management
- Internal Audits and Management Reviews
- External audits for certification
- QMS management