Medical industry regulations surpass stipulations in critical areas of other industries such as aerospace and automotive systems. However, when considering the nature of the medical industry, this distinction seems appropriate, as medical devices are designed and built to preserve, save or enhance the quality of human life. As such, they demand the highest level of scrutiny. Several organizations contribute to the myriad of medical device regulations and standards. For example, the ISO is responsible for two widely implemented global standards—ISO 13485 and ISO 14971. These standards define the guidelines for quality and risk management, respectively.
For medical devices utilized in the US, the most important rules and guidelines are defined by the FDA under CFR 21-H Part 820. These regulations cover everything from the building of medical devices to how to gain approval for their use. As many of today’s medical devices are composed of electronics, familiarity with these regulations is mandatory for anyone developing circuit boards for medical devices.
Most Important FDA Regulations for PCBA Development
The PCBA development process consists of three distinct stages:
The process is cyclical, and manufacturers typically complete several iterations to attain the high level of quality required for medical device boards. And while CFR 21-H applies to all entities involved in medical devices manufacturing, specific regulations govern the PCBA development process.
Important FDA Medical Device Regulations for PCBAs
- Part 801
- Labeling requirements for all medical devices
- Part 803
- Reporting requirements for all medical devices
- Part 807
- Registration and listing requirements for entities and medical devices
- Part 820
- Quality system requirements for all aspects of development
Failure to comply with the requirements listed above could result in your medical device not being approved for usage. Still, satisfying regulations for labeling, reporting, registration and listing are far less demanding than the quality system (QS) requirements.
PCBA Manufacturing for Extreme Environments - Part 1
Satisfying FDA Quality System Requirements for Medical Devices
The FDA QS requirements refer directly to the manufacturing of class 1, class 2 or class 3 medical devices, which differentiate between devices based on the level of patient risk. Implantable devices, such as defibrillators and pacemakers, are designated as class 3, while most invasive devices are considered class 2 or class 3. These FDA classifications do not necessarily align with the IPC 6011 classifications for PCB manufacturing quality. The table below displays a more appropriate correlation.
|FDA Classifications||IPC Classifications|
|Patient Risk||FDA Class||IPC Class||Board Reliability|
As patient risk increases, so does the need for heightened board reliability. However, all medical devices should operate safely, regardless of their classification. Understanding this distinction is critical for your medical device manufacture.
Ensuring Your PCBAs Satisfy Medical Device Regulations
Unless you build your boards in-house, meeting the high standards of quality established for medical devices rests with your CM. Therefore, the best way to satisfy these requirements is to follow guidelines like the following:
Guidelines for PCBA Medical Device Regulations Compliance
- Choose a CM that can meet your quality requirements
The best way to satisfy this guideline is to work with CMs that are ISO 13485 certified, as this global standard meets FDA requirements.
- Ensure your CM knows and complies with FDA CFR 21-H regulations
FDA regulations can be complicated as they are wide-reaching and cover all aspects of medical device production. Therefore, you should work with a CM that knows the applicable standards and how to ensure compliance.
- Collaborate with your CM early and throughout the development process
Medical device development often requires iterative design changes due to revised performance objectives, changing regulations or other unanticipated events. The best way to mitigate the impact of such occurrences is to develop and maintain an open, transparent and collaborative relationship with your CM, along with an agile manufacturing process.
|Tempo's Advanced Custom PCB Manufacturing Service for Complex Medical Systems Development
By implementing these simple but important steps in determining who will build your boards, you can ensure they will meet the applicable FDA medical device regulations. Tempo Automation is the leading manufacturer in the industry for fast and precise complex board manufacturing. Additionally, our ISO 13485 and ISO 9001 certifications express our dedication to the highest quality standards for PCB assembly.
And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.
If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you’d like more information on how to ensure compliance with medical device regulations for your board development, contact us.