After years of ISO 13485 compliance, MTD Micro Molding, a developer in micro-injection molding for the medical device industry, announced it has achieved ISO 13485 certification for its services in micro component manufacturing for their medical device customers.
ISO 13485:2003, Quality Management Standard for Medical Devices, is an ISO standard that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with additional requirements, including regulatory, that are specific to the medical device industry.
- focus on risk management activities and design transfer activities during product development;
- specific requirements for inspection and traceability for medical devices; and
- specific requirements for documentation and validation of processes for medical devices.
MTD Micro Molding