After years of ISO 13485 compliance, MTD Micro Molding (www.mtdmicromolding.com), a long-time leader 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.
“The addition of ISO 13485 certification, along with our ISO 9001 certification, affirms MTD Micro Molding’s commitment to our customers in the medical industry”, states Dennis Tully, President of MTD Micro Molding. “This achievement provides our current and future customers a high level of confidence in MTD Micro Molding’s development of critical components for medical devices.”
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. Requirements include:
- focus on risk management activities and design transfer activities during product development
- specific requirements for inspection and traceability for medical devices
- specific requirements for documentation and validation of processes for medical devices
Kim Goodwin, Director of Quality at MTD Micro Molding adds, “MTD’s Quality Management System has matured over the years and as we move forward as a micro industry leader, we will continue to advance our systems to the meet the growing requirements of our medical device customers”.
For more information, visit: http://mtdmicromolding.com/certifications/