PCB Manufacturing for the Medical Device Industry: Part 1 – Regulation and Standards

There is no nobler pursuit than the endeavor to save, extend or preserve life. I, for one, hold those who devote themselves to this goal in the highest regard. This includes not only doctors, nurses, clinicians and first responders, but everyone who supports them. The skill and dedication required to work in the medical field are tremendously laudable; however, there would be far less successful outcomes without the amazing technology and electronics on which medical practitioners depend.

Although the human body is a masterful design capable of great feats, it is also fragile and requires regular care. The systems that allow us to care for our bodies range from small wearable devices that promote wellness to full-body imaging systems that analyze the health of internal organs. Whether these medical devices are used for patient care, research or training medical professionals, they comprise electronic components and PCBs. As such, there are strict medical device regulations and standards governing their manufacture.


Overview of Medical Device Regulations and Standards

The medical device industry is broad and virtually everyone has, or will, encounter a medical device at some point in their life. The accuracy of medical device measurements or precision of operation can determine whether a condition is properly diagnosed, the proper treatment is provided, or the desired prognosis is delivered. To ensure medical devices meet their critical system performance mandate, the International Electrotechnical Commission (IEC), International Standards Organization (ISO), US Food and Drug Administration (FDA), Federal Communications Commission (FCC) and other agencies publish medical device regulations and standards to which companies building and supplying medical equipment must comply.

Important Medical Device Regulations

To a great degree, medical device regulation is geo-controlled, with each country having its own governing bodies and standards. However, meeting the qualifications of agencies like IEC and ISO is typically sufficient to satisfy most countries. Additionally, the fact that medical devices are so varied and used in many different areas means there are specific regulations for specific devices, depending on how they are used. Due to these realities and the continuously evolving nature of regulations, creating a complete listing is virtually impossible. However, to supply organizations with medical devices and equipment, there are a few key regulations you should be aware of.

  • IEC 60601: Medical Electrical Equipment
    • Part 1-1:12 - General requirements for basic safety and essential performance for various equipment types.
    • Part 2-1:68 - Particular requirements for the basic safety and essential performance of various medical equipment types.

Defines the requirements for a quality management system (QMS) that is specific to the medical devices industry.

Defines a process of identifying medical device hazards, including in vitro diagnostic (IVD) medical devices as well as analyzing, controlling and monitoring the associated risks.

Requires that all manufacturers (foreign and domestic), accessory manufacturers, distributors, repackagers, relabelers, specification developers, reprocessors, importers and exporters register their organization with the FDA.

Defines the electromagnetic interference (EMI) requirements for certification of electronic equipment that contains or is an RF device (defined as any device that is capable of emitting energy in the 9 kHz - 3000 GHz frequency range).

The specific regulations your medical device is subject to may vary and potentially include additional specific standards; however, the above should help you pave the way to meet additional requirements, if necessary.

Manufacturing PCBs to Meet Medical Device Regulations and Standards

As seen above, medical devices are heavily scrutinized before they can be used to support the mission of industry practitioners. Due to these medical regulations and standards, the pool of contract manufacturers that are available is far smaller than for other PCB manufacturing. Therefore, it is incumbent upon you to be discriminatory when choosing your critical system CM. A first step is understanding the importance of design for manufacturing (DFM) and how your decisions can aid the PCB manufacturing process for your medical devices. Next, you need to determine the type of board fabrication and PCB assembly services you need. Finally, you need to ensure that your CM can meet your qualifications for medical device manufacturing. To assist you, here is a set of questions to ask your CM:

Questions to Ask Your CM

  1. Have you built boards for other medical device companies?
  2. Do you employ methods, such as traceability, to avoid using counterfeit components?
  3. What quality assurance practices do you employ as part of your PCB manufacturing service?
  4. Do you employ manufacturing testing methods to ensure PCB quality and adherence to IPC 6011 rigid, rigid-flex and flex standards?
  5. Are you ISO 9001 certified?
  6. Will you support me in meeting the IEC 60601 general and particular requirements for my medical device?
  7. Will you support my adherence to ISO 13485 and ISO 14971 quality management and risk management medical device regulation (if necessary)?
  8. Are you able to make recommendations and suggestions that will assist me in meeting FCC Title 47 requirements that may be applicable to my medical device?

Your CM’s responses to the inquiries above will provide a good indication as to whether or not they’re capable of building boards that meet your requirements. It will also help you better understand whether their operations will support your medical device regulation requirements.

The PCB Design Development Checklist

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Tempo‘s Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development

●   Accurate quote in less than a day.●   DFM support from Day 1 of design.●   Fastest turnkey PCB manufacturing in the industry.●   Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.●   Custom automated BOM verification tool. ●  Sources components from the most reputable suppliers in the industry.
●   Software-driven robotics assembly.●   Multiple automated inspections during PCB assembly to ensure PCB quality.●   Design testing capabilities; including Flying Probe.
●   Superior open, transparent PCB manufacturing experience.

Tempo Automation is the industry leader in high quality, precise and fast PCB prototyping and low volume production. We are experienced in building PCBs for medical device applications and other critical systems. As your partner in your board’s development, we are committed to ensuring that you have a superior PCB manufacturing experience and your boards meet all your qualifications.

And to help you get started on the best path, we furnish information for your DFM and enable you to easily view and download DRC files. If you’re an Altium user, you can simply add these files to your PCB design software.

If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on medical device regulation or how we can support regulatory requirements while manufacturing your PCBs, contact us.

In Part 2: Development of this series, we will discuss essential considerations for your medical device development process.

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