The race is on to achieve ISO 13485!
I’ve written in the past about the critical importance of ISO 13485, but if you don’t know what it is, let me tell you. It’s an official ISO standard that enables a certified company to manufacture medical devices. The standard essentially ensures that the manufacturer includes a number of processes and controls to increase the safety and reliability of produced medical devices.
Without such a certification, a 3D metal printing service would have a much smaller market, as any attempts to sell printed parts to a buyer would result in the inevitable “you DO have ISO 13485, don’t you?” The answer had better be “Yes”.
Very few 3D printing companies have achieved this standard yet, but more are coming online as time passes. Two of note recently include a 3D printing service and a metal powder maker.
UK-based LPW Technology, makers of high quality metal powders and sophisticated associated equipment recently issued a press release indicating they’ve got the certification:
LPW Technology Ltd, the market leader in the development, processing and supply of high quality metal powders and software solutions for the Additive Manufacturing (AM) industry, has again achieved certification to ISO 13485 standard for medical devices at its UK facility.
Successful certification to this standard requires the due diligence of everyone in the organisation, completing their roles to the highest of values, and following the requirements of ISO 13485 and LPW’s procedures and systems. LPW achieved the standard with no critical, major or minor non-conformances.
Note that they are a materials company, not a 3D printer manufacturer; the certification is required for ALL elements of the process leading to the production of the medical device, not just the printer. The material counts just as much, particularly when there are metal powder handling systems required.
On the other side of the Atlantic, Canada-based Precision ADM, a 3D metal printing service, also announced they’ve achieved ISO 13485 certification. They explain:
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.
One could say they’re joining the ISO 13485 3D printing club, or you could also say they’re gaining a leg up on their competitors that don’t yet have the certification.
The bottom line here is that if you want to be in the 3D metal printing business, you’d best get certified for ISO 13485.
Either that or work for GE.