Medical PCB Assemblies – Standard and Regulatory Challenges Discussed
Printed circuit boards (PCBs) have become an integral part of machines and equipment in the medical sector, and this advancement has transformed the way healthcare centers function. As technology continues to advance, an increasing number of medical research, diagnosis, and treatment methods are digitalized and even automated. This means PCBs are becoming a standard requirement for several segments in the medical industry. The global market for medical PCBs is projected to reach $4.1 billion by 2026, growing at a compound annual growth rate (CAGR) of 3.8% from 2021. This growth is driven by the increasing demand for medical diagnostics and wearable devices, which rely heavily on PCBs for their functionality. However, the process from designing and manufacturing to assembling these PCBs requires strict compliance with industry standard and regulation, which may pose some challenges for the manufacturers Would you like to know the standards and regulatory challenges for medical PCB assemblies?
Significance of Standard and Regulations for Medical PCBs
Before getting into specific challenges, it's essential to understand the significance of standards and regulations in the medical industry. Most medical devices operate in life-critical scenarios where failures can have severe consequences, including life-threatening situations. To prevent such situations, it is mandatory for any diagnostic equipment to give accurate readings and hence these devices must meet certain standard. Manufacturers must meet high-quality production criteria by adhering to stringent standards and regulations, ensuring that the components function as intended under various conditions. These standards also mandate thorough testing and validation processes, minimizing device failure risk. Regulatory bodies, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, enforce these standards to safeguard public health and maintain product quality.
Standard Challenges in Medical PCB Assemblies
Here are some standard challenges medical PCB manufacturers may confront during the process.
- IPC Standards: The Institute for Printed Circuits (hence the acronym IPC) is now being named the Association Connecting Electronics. This institute sets specific standards for medical PCBs to ensure reliability and performance. Manufacturers must keep up with the evolving IPC standards. However, this can be challenging for some manufacturers as it requires continuous training and investment in updated equipment and processes.
- Material Selection: Unlike standard PCBs, medical PCBs require specialized materials to meet stringent performance and safety standards. Experts can find it challenging to choose materials that comply with regulatory standards while balancing costs.
- Miniaturization: Many medical devices are compact and portable. Therefore, PCBs used in these devices must follow suit. Miniaturizing circuit board assemblies without compromising functionality or reliability requires advanced design techniques and precise manufacturing processes.
- Signal Integrity: Maintaining signal integrity is paramount in medical PCB assemblies. Impedance control, electromagnetic interference, and signal loss must be managed carefully to ensure reliable operation.
- Reliability Testing: Medical devices are used in harsh environments and demanding usage scenarios. Therefore, these PCBs undergo rigorous testing to ensure they withstand challenging situations and meet all the required parameters. To validate their performance and longevity, medical PCB assemblies must undergo extensive reliability testing, including vibration testing, temperature cycling, and accelerated aging.
Regulatory Challenges in Medical PCB Assemblies
The below listed are typical regulatory challenges in the medical PCB assemblies.
- ISO 13485 Certification: This is the most crucial standard for manufacturers as it decides the quality management system for devices in the medical industry. Achieving and maintaining ISO 13485 certification is essential for demonstrating compliance with regulatory requirements and ensuring consistent product quality.
- FDA and Regulatory Compliance: Medical devices must comply with FDA regulations to be legally marketed and sold, especially in the USA. This includes adherence to quality system regulations (QSR), premarket submissions, and post-market surveillance requirements. Navigating complex regulatory settings requires expertise in regulatory affairs and thorough documentation throughout the product lifecycle.
- Risk Management: Manufacturers must identify and mitigate potential risks associated with PCB assemblies. Electrical malfunction, component failure, or software errors are some common issues. Manufacturers can identify these risks through comprehensive risk management processes.
- Labeling and Documentation: Accurate and comprehensive labeling and documentation are critical for medical devices. This ensures proper use, traceability, and compliance with regulatory requirements. PCB assemblies must be labeled with essential information such as part numbers, manufacturing dates, and regulatory certifications.
- Post-Market Surveillance: After the timely delivery of a medical device, manufacturers are responsible for monitoring its performance and addressing any safety or quality issues that may arise. Establishing robust post-market surveillance processes, including complaint handling, adverse event reporting, and corrective and preventive actions (CAPA), helps ensure ongoing regulatory compliance and patient safety.
Designing, manufacturing, and assembling medical PCBs demand manufacturers to follow stringent standards and regulations. However, staying informed, investing in quality management systems, and partnering with experienced players help overcome these challenges, and deliver safe and reliable medical devices. If you need PCBs for your next medical equipment, you must consult a reliable and experienced player in this segment. Accelerated Assemblies may be the best choice. The company is ITAR certified, providing PCB assemblies for the medical industry for years. Get in touch with their experts to know more about their services.
