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).

Steps to a Successful Medical Device PCB Build

If your medical device project will include PCB design and assembly, take these factors into consideration:

ISO 13485 BENEFITS SUMMARIZED

Because of strict industry requirements, companies responsible for selling finished medical devices score some important benefits when using a ISO 13485 certified manufacturer, including:

• Thorough, clear understanding among all parties of the device’s end use, avoiding errors in design and manufacturing
• Risk analysis methods that are well-defined and effective to avoid expensive safety problems that appear after final production
• Focus on the end-user to ensure ease of use, safety, and effectiveness
• Audits to make contractors fully accountable for product quality and safety

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.

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A Foundation of Success

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.