Canada Makes partner Precision ADM Inc. is pleased to announce that it is the first Canadian metal Additive and Subtractive manufacturing services company to receive ISO 13485:2016 Quality Management System certification. This industry standard represents the comprehensive set of requirements for the design and manufacture of medical devices.
Implementing this standard enables Precision ADM to manufacture medical devices, such as Orthopaedic Implants, using the latest digital manufacturing technologies. Using these technologies, Precision ADM can lower production costs by reducing waste and decreasing time to market by simplifying – or eliminating – tooling and equipment.
Additive Manufacturing also makes it possible to produce custom, patient-specific designs and devices with complex geometries, with potential lower cost than traditional manufacturing methods. Precision ADM is currently targeting additively manufactured medical devices produced in materials such as Titanium, Cobalt-Chrome, and stainless-steel alloys.
“Achieving ISO 13485 Registration and Certification using both metal Additive and Subtractive Manufacturing methods for Medical Devices is a first for any Canadian AM services company,” said Martin Petrak, CEO. “We are proud of our team’s accomplishment in achieving this significant milestone and are excited to work under this quality system with our existing and new clients.”
Dale Kellington, General Manager, added “The design and manufacturing controls this Certification demands gives our medical device customers the confidence they need that our manufacturing output will meet their stringent requirements. Our experience in product innovation and validation testing through our parent company, the Orthopaedic Innovation Centre, gives us a unique perspective on medical device manufacturing.”
“The expertise and experience our engineers possess give us the ability to solve the complex issues facing the medical field today,” said Derek VanDenDriessche, Director of Medical Sales.