ISO 13485 Certification for Medical Device Manufacturers
ISO 13485:2003 is a quality system standard designed specifically for medical device companies, its Benefits of Certification For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. The ISO 13485 standard has many of the same requirements as ISO 9001:2008. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback and more.Benefits of ISO 13485 Medical Devices
- Increase the probability of making safe and effective medical devices
- Increase access to more markets worldwide with certification
- Meet regulatory requirements and customer expectations
- Demonstrate that you produce safer and more effective medical devices
- Increased Efficiency
- Cost Savings
- More Effective Risk Management and Quality Assurance
- Improved ability to respond to Customer Requirements