The importance of outsourcing to an ISO 13485 Certified Electronics Manufacturer for Medical Devices

Medical device OEM’s have a lot to consider in their search for a reliable electronics partner but finding an experienced ISO 13485 Certified Manufacturer should be their first consideration.

The medical industry plays a vital role in society and to allow it to function correctly OEM’s need manufacturers proven to meet the high standards required. The difference between functioning and non-functioning medical devices could mean life or death so safety standards must be the priority.


What does ISO 13485 certification actually involve and why is it so reassuring?

The standard ensures that safeguards are in places for medical manufacturers, including:

  • Record keeping
  • Device history records
  • Regulatory requirements for documentation and records
  • Product and process verification procedures are carried out on protocols specific to medical devices
  • Entire supply chain evaluation
  • Annual Auditing

By demonstrating the above, an electronics manufacturer can reassure regulators and customers that their electronic components have met rigorous safety standards by a third party and therefore met all the requirements for producing safe goods.

Medical devices require extremely reliable and long-lasting components so it’s important that their supply chain is re-evaluated to assure customers that part of this process is held to the highest standards.

What about the ISO 9001 certification you may be wondering? Although that’s a vital certification for an electronics partner to have it’s not enough in the medical world. If a contractor has ISO 13485 certification, it also has ISO 9001 certification. ISO 13485 basically adds a further layer (that holds more weight in the medical world) to the foundation of the ISO 9001certification.

To summarise, the first question when an OEM is researching an electronics or other medical device component manufacturer should be: “Are you ISO 13485 certified?” The answer should determine the OEM’s next move.

Are you looking for an electronics manufacturer that holds an ISO 13485:2016 – Medical Devices accreditation? UK Electronics received their accreditation in March 2019 so we can confidently offer medical device product development, manufacture, and PCB assembly whilst incorporating basic medical device safety standards.

Contact us today to discuss your next medical device project.

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