Precision ADM medical device certified
Precision ADM Inc. has received ISO 13485:2016 Quality Management System certification for the design and manufacture of medical devices using metal additive and subtractive manufacturing techniques.
The company becomes the first of its kind in Canada to receive the certification.
Using the latest digital manufacturing technologies, and now with the ISO 13485:2016 standard in place, Precision ADM is in position to manufacture medical devices, lowering production costs by reducing waste and decreasing time to market. The company also expects to simplify, and perhaps eventually eliminate, tooling and equipment, which will also result in cost savings.
In addition to the economic benefits, Precision ADM has sought to leverage additive manufacturing to take advantage of its renowned proficiencies in the production of customised, patient-specific devices with complex geometries. So far, the Winnipeg-based company has outlined titanium, cobalt-chrome and stainless steel alloys as material groups it will target.
By combining the company’s expertise with the certification standard it was granted last month, Precision ADM is confident it can solve ‘the complex issues facing the medical field today.’
“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 of Precision ADM. “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, Precision ADM 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 Center, gives us a unique perspective on medical device manufacturing.”
