Adhering to industry-specific rules and regulations is critical for anyone manufacturing printed circuit board assemblies (PCBAs) for medical devices. The FDA holds a unique set of requirements outlining compliance not only in medical printed circuit board manufacturing but also in recordskeeping. ISO and IPC requirements must also be followed while ensuring quality control throughout the prototyping and production cycles.
This guide explains what medical device manufacturers and the circuit producers that support them must know to develop medical PCBs and devices in compliance with all applicable standards.
Numerous medical devices rely on printed circuit technologies, ranging from at-home monitoring tools to sophisticated diagnostic equipment. Even the smallest of implantable devices relies on medical PCBs to function. Some examples include:
These devices must function precisely and reliably; even the smallest of defects could put a patient’s life at risk. For these reasons, there are several federal and industry regulations that must be adhered to by medical PCBA manufacturers and those manufacturing and testing the fully assembled device.
Authorities like the Institute for Printed Circuits (IPC), the International Organization for Standardization (ISO), and the U.S. Food and Drug Administration (FDA) have all released standards related to circuit boards used in medical equipment. The guidelines include every aspect of the development and manufacturing process, from design to final approval.
Let’s go deeper into each of these organizations and their regulations.
The Institute for Printed Circuits regulates the assembly and production of electronic components and assemblies. The group has developed and released several critical standards:
IPC standards for medical PCBs can also include regulations applicable to:
Visit the IPC website to learn more about applicable standards.
The International Organization for Standardization (ISO) develops and publishes a range of standards related to the design, manufacture, and testing of circuit boards.
The United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) imposes laws on companies that manufacture, re-label, re-package, and import medical devices in and into the U.S.
Operating within the FDA is the Center for Devices and Radiological Health (CDR). This component of the organization monitors electronic products that emit radiation, including X-ray equipment, lasers, ultrasound devices, and others.
The FDA categorizes medical devices into three classes:
In compliance with these standards, Tier II printed circuit manufacturers must keep detailed records for every component they produce for medical device PCB assemblies. If there is ever an issue in the field with a medical device, the FDA requires traceability to determine whether the defect was due to a faulty component in the circuit or another part of the device. These records must be kept indefinitely.
The categories below apply only to medical device manufacturers, not those who manufacture the printed circuit assemblies.
Domestic and foreign manufacturers must register with the Food and Drug Administration. This takes place electronically unless the organization issues a waiver. Manufacturers must complete an annual verification of their registration information between October 1 and December 31 of each year. Overseas manufacturers must also appoint a U.S. representative.
Manufacturers must comply with medical device listing requirements, including the following types of businesses:
This applies to United States manufacturers of devices for export only.
Quality system regulation involves defining and meeting requirements related to various aspects of medical devices, including:
Manufacturing facilities are subject to FDA inspections to ensure compliance with their standards.
According to the FDA, labeling includes the physical device label, its description, and any additional informational text that is included with the device.
The fundamental rationale behind the Food and Drug Administration’s MDR regulation is to identify significant adverse issues related to medical devices and to monitor them on an ongoing basis. It’s a requirement to notify the organization about anything that may have caused severe problems, injuries, or death. All device malfunctions must also be reported. The goal is to uncover and fix issues as soon as possible.
This law, the Medical Device User Fee and Modernization Act, allows the FDA to conduct medical device premarket notification 510(k) reviews and charge fees for it. Certain businesses could be eligible for reduced costs. Under this law, a business cannot distribute a device requiring a 510(k) submission until the FDA demonstrates valid equivalence.
Class III products require premarket approvals because they present a significant risk of illness and injury and cannot be compared directly to less-risky class I and II products. Premarket approval is a highly complicated process that includes submitting clinical data to support any claims about the device.
Medical device regulations are complex, and the process of receiving FDA approval can take several years. Understanding all aspects of compliance and working with manufacturers knowledgeable in medical device PCB manufacturing will help you avoid circuit design issues and ensure no critical steps are missed in the process.
Tramonto Circuits provides engineering and manufacturing support for prototyping and production. Our diligence and 99% quality ratio ensure the circuits used in your devices meet all applicable standards. Contact our engineers to learn how we can support you.
