The healthcare industry has seen continual enhancements in technology over the years, giving doctors and nurses new tools and instruments to treat their patients. Most people have probably used the different online services available with your doctor’s office or your local pharmacy, but that is just the tip of the iceberg. Robotic surgery and mobile diagnostic tools are a few of the new and advanced devices available in health care.
Many of these new tools require advanced electronics to drive their functionality. These circuit boards usually have to be developed quickly to meet a new and pressing need while maintaining the highest level of quality to ensure safe and reliable treatment. Achieving these goals requires adherence to an elaborate array of electronic requirements for medical devices, including industry standards of conformity and manufacturability. Here are some of the requirements that contract manufacturers have to meet to build electronics for medical devices.
Certification to Build Electronics According to Industry Standards
Industry standards cover many of the electronic requirements for medical devices. Some of these standards cover basic workmanship, while others set infrastructures in place for measuring and documenting the quality of the final product. There are also specific medical equipment standards, such as those that detail how much electromagnetic interference is allowed in a device. While these standards serve as published guidelines for design and manufacturing, some also offer certification and training programs. Here are some of the standards that a PCB CM should be familiar with and certified in for building medical electronics:
- ISO 9000: This is a series of standards covering the quality and reliability requirements of the design, manufacturing, and electronics testing. This series offers certifications, and most PCB CMs will be certified in ISO 9001.
- IPC-A-610: The IPC series of standards pertain to many aspects of printed circuit boards, with IPC-A-610 covering the acceptability of electronic assemblies.
- CFR 820: This standard is published by the food and drug administration (FDA) and provides a quality system for validating manufacturing and quality control processes.
- IEC 60601-1-2: This details the EMI standards that electronic medical equipment and systems need to be tested for by accredited laboratories.
Another important industry standard that contract manufacturers building medical equipment should be certified in is ISO 13485. This quality management system standard goes into depth specifying quality and reliability requirements for medical products. One of the key features of ISO 13485 is how it defines the criteria for a tracking system to document all components and materials used to manufacture medical equipment. Next, we will examine why this type of tracking is an essential requirement for PCB contract manufacturers.
Traceability Electronic Requirements for Medical Devices
The FDA strictly enforces product identification in medical equipment, and manufacturers need to have a documentation system that allows them to track every detail of what they build. Not only do all the parts and materials used to build the device need to be trackable in case of a recall, but certificates of compliance, test results, and other product data should be included as well. Additionally, software and hardware configurations should be added to the tracking documentation to help with future improvements and enhancements of the product.
To satisfy the tracking requirements of ISO 13485, PCB CMs will typically put a documentation system in place that tracks circuit boards by their serial number. The documentation will include purchase order information, components, and other build items such as panels, wire harnesses, and even the raw (un-assembled) circuit boards. The documentation system should also track manufacturing steps, testing procedures, and the different technicians that worked on the board. The components and materials used on the circuit board will be managed with a barcode tracking system. A database stores all of this information and data, where individual reports can quickly be sent back to the customer.
Now that we’ve seen some of the industry requirements for building medical electronics, let’s look next at the general manufacturing capabilities a PCB CM should have.
Essential Manufacturing Capabilities for Building Medical Electronics
There is no substitute for experience, and that certainly applies to building medical electronics. A PCB CM should have a good reputation for building high-quality equipment, and that should be supported by the certifications that we have just discussed. Additionally, a PCB CM should list the following among their capabilities:
- Quick-turn and high-quality production: A PCB CM must be able to respond to the needs of their customers quickly and at the highest levels of quality.
- Local on-shore production: For a working relationship that doesn’t have to contend with shipping, tariffs, garbled communication, and delayed responses due to time zones, it is best to work with local PCB CMs.
- Box-build capabilities: Quick production of new medical devices often requires chassis, cables, and wiring harnesses. It saves a lot of time and effort if all of this is produced in the same facility.
- Supply chain management: With components and other critical-path materials in high demand and short supply, it’s essential to use a PCB CM with a well-developed network of manufacturers, distributors, and brokers. These supply chain connections alone can make the difference in getting medical electronics built on time and within budget.
- Engineering resources: A PCB CM with an experienced engineering staff can review a design collaboratively, looking for potential enhancements to improve manufacturability yields. Not only will this prevent delays during fabrication and assembly, but it will lower the final production costs.
How Local PCB Contract Manufacturers Provide the Services You Need
PCB contract manufacturers like VSE offer all of the necessary services and capabilities to produce electronic medical equipment. For instance, VSE features the following for clients:
- Certified in ISO 9001 and ISO 13485.
- IPC corporate member with certified IPC-A-610 trainers on staff
- Offers identification and tracking systems that contain all of the parts, materials, processes, and personnel data recorded for each project
- High-mix, low-volume production lines give customers the flexibility for quick changes, prototype builds, and new product introductions (NPI)
- Prepared to handle all medical device assembly needs, from circuit board production to full box-build and wire harness construction