ISO 13485 Contract Manufacturer for Medical Device PCBA

Arguably, no industry directly affects our lives more than healthcare. Our healthcare workers enable many people to enjoy life much longer than would have been possible just a few decades ago. Medical devices offer clear examples of the rate and extent of recent innovations in life-preserving technology.

Medical devices fall into three classifications based on the risks associated with their use. The riskiest of these, which fall under class 3, include minimally invasive and invasive medical devices.The operational precision and accuracy of these devices—along with other laboratory and testing equipment—are made possible with electronic circuit boards.

The medical industry imposes numerous regulations and standards to ensure the safety and quality of these advanced medical devices. To meet these criteria, you should rely on an ISO 13485 contract manufacturer to build your medical device PCBAs.

Batch of high-quality medical device PCBAs

Why You Need an ISO 13485 Contract Manufacturer

The most important standard for medical device PCBA design and development is ISO 13485, which provides guidelines and requirements for a quality management system (QMS) that ensures medical devices achieve the high standards for safety and quality. To meet these industry expectations, manufacturers must know how integral proper board building is in successfully adhering to the standard.

ISO 13485 Manufacturing Requirements

Product realization planning

Design and development

Purchasing process


Monitoring and measurement

For turnkey medical device PCBA manufacturing, your CM should be a principal for each of the essentials listed above. And it is important that your CM does not simply claim adherence but is also a certified ISO 13485 contract manufacturer.

Tempo’s Digital Thread ISO 13485 Certified Manufacturing Process

Tempo Automation is the industry leader for fast, high-quality prototyping and on-demand PCBA manufacturing. To accomplish this, we apply our digital thread manufacturing process that emphasizes software-driven automation and quality assurance at our facilities.

Additionally, we work closely with you and provide the following services to support your ability to deliver ISO standard 13485 compliant boards to customers.

Tempo’s ISO 13485 contract manufacturing facility in Silicon Valley
  • Transparency
    • We keep you informed of exactly how we are manufacturing your boards and provide an online tracker so you can monitor the progress of your builds.
  • Commitment to quality
    • Our certifications and track record speak volumes about our commitment to quality. Both prove that our process meets the most important quality standards for our industry, including being an ISO 13485 contract manufacturer.
  • Supply chain security support
    • We work with a small group of the industry's most reliable suppliers to ensure the security of the components installed on your boards and avoid delays that could threaten your ability to deliver on schedule.
  • Documentation control
    • Because our process is software-based, comprehensive and accurate documentation is critical. Therefore, we understand the importance of data traceability and provide you with all necessary documentation to satisfy your ISO 13485 requirements.
  • Agile manufacturing process
    • Our process requires the ability to institute changes quickly and with the least amount of process disruption. This type of agile manufacturing is important for medical device development.

Partnering with an ISO 13485 Contract Manufacturer

Providing all of the above allows us to optimize the building of medical device PCBAs.

Tempo’s digital thread manufacturing process leads the PCBA industry in building custom and complex boards quickly and precisely. We deliver on-demand PCBAs that meet the high-quality standards of your applications. If you are ready to have your design manufactured, use our online quote tool to upload your CAD and BOM files. For more information on our advanced turnkey PCBA services, contact us anytime or call or text us at (312) 869-9070.

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