As medicine evolves, medical devices are also undergoing significant changes. Original equipment manufacturers (OEMs) and electronics manufacturing service providers (EMS) must keep pace with current trends in the medical industry while ensuring the safety and usability of their products and aligning them with industry standards. To achieve this, they should be prepared to tackle common issues related to PCB assembly for medical devices.
Medical device safety and quality
All electronic devices must be safe and reliable and this is especially true for medical equipment. Medical electronic devices that come into direct contact with the body, are frequently exposed to vibration, high humidity, liquids, and temperature fluctuations. In addition, high precision is required from many medical devices with measuring functionality.
While OEMs take care of the design of their products, an EMS provider is focused on the production and all phases that can affect the quality of the devices. Poland-based Assel, for example, handles supply chain management, including sourcing, inspecting, and storing components according to industry standards and OEM’s requirements.
Achieving high product quality is impossible without a thorough assessment. That is why it is essential to partner with an EMS provider that also offers professional testing services.
Although an EMS provider produces devices according to the OEM’s technological requirements, a competent manufacturer can identify technologically obsolete designs and suggest more modern, effective, and safer alternatives. Additionally, an EMS provider can advise an OEM on the choice between Surface Mount Technology (SMT) and Through-Hole Technology (THT), which are commonly used for PCB assembly.
Meanwhile, OEMs should ensure that the EMS provider they choose has experience working with miniaturised components that require particular precision and advanced PCB assembly technology.
To produce high-quality medical devices and comply with strict market regulations, it is highly recommended to cooperate with an EMS provider with sufficient expertise to manufacture devices aligned with the design provided by an OEM, which in turn must be compliant with industry requirements. For example, for the EU market it would be the MDR (Medical Device Regulation).
At the same time, it is imperative for an EMS provider to hold ISO 13485 certification for electronics manufacturers. It demonstrates their diligent adherence to the stringent quality standards of the electronic medical device industry through effective risk management, maintenance of product traceability, and continuous control of the production process, as well as other practices that contribute to the quality and safety of the final product.
Errors in the production of electronic medical devices can have particularly drastic consequences for manufacturers and end users. For this reason, choosing an experienced and certified EMS provider is critical. To learn more about working with Assel, visit https://asselems.com/en/medical-electronics-manufacturing