Many medical device original equipment manufacturers (OEMs) prefer to outsource one or more aspects of their manufacturing processes to medical device contract manufacturers (CMs). The area of expertise they wish to outsource can be anything ranging from research and design to assisting with the actual manufacturing process. Since custom fabrication has to be professionally done, selecting the right medical device CM can be critical to the success of an OEM. Below we will discuss some criteria that you should review when selecting a medical device contract manufacturer.
ISO 13485 Certification and Other Accreditations
ISO 13485-certified medical device contract manufacturers have the necessary quality management systems to produce components or devices for OEMs that need to consistently meet the most stringent regulatory and customer requirements. Regardless of their sizes or types, they are usually capable of contributing to any stage in the lifecycle of a medical device. FDA approval and risk mitigation plans are other accreditations that a medical device CM should possess.
Cleanroom Capabilities
It is also important that OEMs choose medical device contract manufacturers that have excellent cleanroom facilities. This is because devices that are made in cleanrooms are significantly less likely to be contaminated, and they are usually of a higher quality. A good medical device CM should have ISO 14644 and ISO 14698-compliant cleanrooms, as well as Class 10,000 cleanrooms or better.
Responsiveness and Punctual Delivery
An OEM cannot waste time waiting for a CM to respond. As such, it is essential to choose a medical device CM that can respond quickly and provide project updates frequently. Similarly, an OEM should also make sure that the CM has an impressive track record of on-time delivery.
With so many medical device contract manufacturers to choose from, it can be difficult to make the right decision. However, the points above can help you narrow the field down to a few good candidates.