Nadcap vs. AS9100 Standard for Electronics: What's the Difference?
If there's one thing that takes center stage in the aerospace industry, it's safety. This, of...
Medical devices and equipment are Class 3 electronics, which means you’re designing to a strict standard. Sometimes medical customers have special requirements and internal expectations that go beyond even Class 3.
The PCB manufacturer you work with needs to be able to meet all the requirements of Class 3 and any other requirements you may have. Some PCB companies specialize in Class 3 products, while others absolutely don’t. Do some investigating before you choose an ECM (electronics contract manufacturer).
If your medical device project will include PCB design and assembly, take these factors into consideration:
Because of strict industry requirements, companies responsible for selling finished medical devices score some important benefits when using a ISO 13485 certified manufacturer, including:
The first question when an OEM courts an electronics or other medical device component manufacturer should be: “Are you ISO 13485 certified?” The answer carries a lot of weight.
Matric has won awards for maintaining on-time delivery. The award qualifications include: a level of quality of less than 3,000 DPM, or 99.7%; on-time delivery of 95% or better; and a minimum sales total.
A manufacturer doesn’t have to be ISO 13485 certified to meet its standards. And it doesn’t have to be ISO 13485 certified to make and sell medical device components or the finished devices. But a medical device manufacturing certification tells everyone, regulators and customers included, that your electronic components have undergone an objective evaluation by a third party and met all the requirements for producing safe goods.
An electronics manufacturer can be part of a long supply chain and, with an ISO certification for medical devices on its side, Matric can assure customers that its part of the process is held to the highest standards.
If you would like more information about how a full-service contract manufacturer can augment the abilities of your company and your equipment, fill out the form, select the services you are interested in, and we will send you more information.