One of my favorite actors of all time is Jack Nicholson. His portrayals of wild men in “The Shining” and “Wolf” are terrifyingly believable. However, his exchange with Tom Cruise in “A Few Good Men” is his true masterpiece. The description of how he and his men accept the responsibility of doing what is necessary to provide the protection that most of the people protected take for granted is riveting. It reminds me of the responsibility that designers and manufacturers of medical electronic devices have to the patients who rely on their work.
The truth is that virtually everyone uses medical electronic devices as defined under Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act for routine monitoring, tests, exams, a surgical procedure, organ replacement or some other vital biological need. Due to the potential for harm or loss of life that may occur when inferior products are used, designers and manufacturers have a mandate to ensure the safety, precision and reliability of these electronic devices and PCBs. This mandate is embodied within the regulations and standards that provide the framework for medical device development. Let’s zero in on the design stage of medical electronic device development and how the necessary standards can be met.
Standards for the Design of Medical Electronic Devices
Medical devices and equipment are subject to more rigid regulation than most other electronics products. This increased scrutiny is justified as the inability of medical electronic devices to operate and perform as expected can have tragic results up to and including the loss of life. Therefore, each stage of medical device development is subject to regulatory oversight to optimize performance. Medical device development follows a well-defined quality management system (QMS) outline wherein potential risks are carefully monitored and analyzed. Compliance with these standards is verified through a number of specific testing regimens. Standards that your medical electronic device may be required to adhere to include the following:
- FCC Title 47 of Electronic Code of Federal Regulations
- US FDA 21 CFR Part 807: Regulation of firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States
- IEC 60601-1: Medical electrical equipment – General requirements for basic safety and essential performance
- IEC 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use
- IPC 6011: Generic Performance Specification for Printed Boards
- ISO 13485 Medical Devices: Quality Management Systems – Requirements for Regulatory Purposes
- ISO 14971 Medical Devices: Application of Risk Management to Medical Devices
How to Incorporate PCB Standards and Requirements into the Design of Medical Electronic Devices
The success of your medical electronic device development is contingent upon incorporating the applicable regulatory requirements, beginning with design. An effective way to accomplish this is to adopt a design paradigm, such as the one below.
A. Determine and satisfy your organization and device registration requirements.
B. Employ quality system management in accordance with FDA 21 CFR Part 820 and ISO 13485 as part of your design plan.
C. Include any labeling requirements as stipulated in FDA 21 CFR Part 801 for your medical electronic device.
D. Ensure that your design incorporates materials that meet IPC 6011 (most likely Class 2 or 3) requirements.
E. Design your device such that it is in compliance with FCC Title 47 for radiation emitting devices, if applicable.
F. Ensure that your product meets the standards of IEC 60601 or IEC 61010 depending on its operating environment.
Incorporating the above standards into the design of your medical electronic devices will assist you in developing high-quality, reliable products for the medical device industry. Another factor that can greatly enhance the chances of your product meeting these standards is your choice of a control manufacturer (CM). Your CM should not only be capable of high-quality board fabrication and PCB assembly but also be an expert partner that can help you make decisions that reflect your design intent. By collaborating with your CM, you can leverage effective manufacturing processes and equipment for the most efficient development of your medical electronic devices.
The development of medical electronic devices requires knowledge of and compliance with a number of standards and regulations. This is not only true for final product testing but the process as a whole, beginning with design.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development|
At Tempo Automation, we are experienced in manufacturing high-quality, precise medical device PCBs quickly. We will partner with you from day 1 of design to ensure that your development process is optimized for manufacturing.
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 the design of medical electronic devices or help with standard requirements for your PCB design, contact us.