There is one thing that is an absolute must when it comes to medical equipment: it has to work as expected, and it has to work correctly every single time it is used. There is no excuse for a defibrillator that doesn’t do what it is expected to, and a surgeon can’t afford to be shocked by malfunctioning instruments when performing a delicate operation. Because of this, medical equipment is built according to some of the strictest and demanding standards in the manufacturing industry.
These strict standards also apply to the printed circuit boards that are at the heart of these medical devices. The standards control how the PCBs are manufactured, documented, tracked, tested, and inspected. The key to getting your medical equipment certified by all of the required regulatory standards in order to get your product to market is to use a PCB contract manufacturer (CM) who understands and works with these standards. Here is how the medical equipment standards and regulations affect PCB manufacturing for medical devices, and what you need to know when working with your PCB CM.
The Different Medical Equipment Standards and Regulations
There are many different standards for manufacturing printed circuit boards, and the ones that apply to your specific board depends on what market segment the board is designed for. There are automotive standards, communication standards, and a host of others. For the medical industry, there are specific standards as well, but as with all electronic manufacturing, there are also some basic assembly standards. Here are some of those standards that your contract manufacturer will probably be working with:
- ISO 9000:The International Organization for Standardization publishes various standards, with the 9000 series covering quality and reliability requirements of design, manufacturing, and testing. Usually, a CM will be certified in one of the ISO 9000 standards, with ISO 9001 being the most likely.
- IPC: The Association Connecting Electronics Industries, otherwise known as IPC, publishes a series of standards for circuit boards. IPC-A-600 covers the acceptability of PCBs, IPC-6012 covers the qualification and performance specification for PCBs. IPC-A-610 covers the acceptability of electronic assemblies, and there are many other IPC standards for enclosures, cables and wire harnesses, and soldering.
- FDA: The United States Food and Drug Administration publishes 21 CFR 820, a quality system regulation for the validation of manufacturing and quality control processes.
These are the more common standards that CMs will be working with. There may be others that apply to specific areas or types of medical devices that are being built.
The Standard for Quality Management when Building Medical PCBAs: ISO 13485
ISO 13485 is one of the most important standards for CMs to become certified in. It is the quality management system standard for devices built for the medical industry. This standard is aligned with some of the ISO 9000 series standards, but it goes more in-depth in specifying quality and reliability requirements for medical products. It is also more closely aligned with other regulatory requirements in the United States, Australia, Canada, and Japan.
One of the key elements in ISO 13495 is that it defines the criteria for a CM to put a documentation process in place in order to track all components and materials used in PCB manufacturing. With a process like this in place, your CM will be able to report to you on everything that was used to build your board. This is essential in the medical industry where manufacturers need to understand the recall procedures for components and materials and have a process in place ready to comply with any recalls or other related regulations.
Here are some of the other highlights of ISO 13485:
- Documented quality control processes: ISO 13485 certification requires that all phases of manufacturing have clearly documented quality control processes. This ensures that products are being built to the medical industry regulations.
- Risk management and design control: Processes must be in place to avoid problems that may impact manufacturing. An example of this would be a review of the bill of materials (BOM) to find and replace components that may become obsolete during the life cycle of the product.
- Process analysis: Another requirement of certification is that manufacturers develop systems of audits and feedback to monitor their own performance. This allows for an analysis of the data to correct and improve their processes should that become necessary.
- Promotion and awareness of other regulations: Another part of being ISO 13485 certified is that it requires that the CM include promotion and awareness of other regulatory requirements as part of their management process. This will give your CM the ability to manufacture products that will ultimately satisfy the requirements of the different regulatory bodies that you work with.
With a full knowledge of the ISO 13485 standard as well as being certified in it, your CM will have the processes in place to manufacture boards that will pass the strict requirements of the medical industry.
Working With a CM Certified in the Medical Industry Standards to Build Your PCBAs
Not all of the standards require contract manufacturers to be certified in order to build medical products. ISO 13485, for instance, does not require certification to itself, and many manufacturers benefit simply by following the standard. But having these certifications demonstrates to both regulators and clients alike that the CM is fully invested in the standard and has the necessary systems and processes in place to satisfy all of the requirements of the standard.
At VSE we are certified in ISO 13485, as well as ISO 9001 and licensed by the state of California to manufacture medical devices. In addition, we also hold a UL 508A certification, we are an IPC corporate member, and we have certified IPC-A-610 trainers on staff. Because we know that building medical equipment to the exacting requirements of the medical standards is essential for your success, one of our highest corporate priorities is achieving and maintaining these certifications.