Are we asking the right questions?
Elmatica announces two new ISO13485 approved manufacturing partners for medical applications in their supplier base.
“The impact from COVID has driven medical manufacturing capacity to its limits and pointed out the importance of a solid and certified supplier base. To have a range of ISO13485 certified suppliers both in Asia and Europe is crucial to meet the different demands of the customers, and has been a priority for us over the last months. Some are in need of QTA, others have a High Mix, Low to Mid volume production”, says Bakke.
The more electronics the more control is needed
Covid has caused reprioritization of the medical production line and defined a new approach for manufacturers selection. Due to order stop in regular production, some manufacturers have been forced to step into unknown production fields of medical equipment, supporting healthcare systems for both on site, and remote diagnosis.
“It is always important to keep in mind when involving yourself in advanced electronic medical production, the more electronics involved, the more crucial to have the correct certification and standards implemented”, says Senior Technical Advisor Jan Pedersen.
“We see the need for certification for the medical sector and the entire electromedical market. Being aware that in the case of products, which are ultimately intended to care for patients’ health, it’s important to use components from qualified vendors meeting the production processes control and traceability requirements for the actual product”, says Country Manager Poland Rafal Stankiewicz.
Initiating, sourcing and controlling
For Elmatica being involved in Medical is a given, not only to support on design related questions, material selections, manufacturing sourcing and compliance, they have also initiated the first IPC standard for Medical Device Applications, the 6012EM released last year and were recently awarded with the Dieter Bergman IPC Fellowship Award for their involvement in standard development.
“For us it’s a priority to work closely with industry partners such as IPC and Universities, grasping on developing the future industrial PCB standards. Developing standards is a time consuming and detailed process, in particular for the Medical Industry, due to the complexity in Medical PCBs”, says Elmaticas Chair of the Medical Addendum Task group, Jan Pedersen.
The importance of specific parameters and requirements for production
With the new standard, the designers and manufacturers of PCB for medical devices can rely on specific parameters and requirements for production, which again will increase the reliability and transparency.
“We experience a higher focus on reliability, and a desire from the customers to involve us at an early stage and through the entire production development. The purpose of the IPC 6012EM is to provide requirements for qualification and performance of Printed Boards for High Reliability Medical Device Applications”, says Pedersen.