Guidelines for Class 1 Medical Device PCB Development

The human brain is an amazing piece of equipment. The number of signals processed, data stored and retrieved and commands issued is “mind-boggling.” One area in which our brains truly excel is pattern recognition. The ability to look at something abstract and find cohesiveness or examine something complex and divide it into manageable sub-systems involves skills that probably underlie our superior imaginative and cognitive abilities. Recognizing patterns is great, but for it to be truly useful, we also need to be able to classify items according to common attributes. Being able to classify based upon similarities has its drawbacks when applied to people; however, it is essential for science and technological development.

The ability to classify electronics systems and devices into categories allows us to enact regulations and standards that can be broadly applied to all members of a category. This, in turn, promotes quality and reliability for products of that classification. This tactic is certainly applicable to the medical industry, where medical devices are categorized as Class 1, Class 2, or Class 3 by the Federal Drug Administration (FDA). First, let’s see what attributes link Class 1 medical devices and then see how that impacts the design and manufacturing of PCBs for these devices.

What are Class 1 Medical Devices?

Medical devices, like other critical systems industries such as aerospace and automotive, are subject to more standards and regulations than most commercial products. Unique to medical devices is the requirement to be registered with the FDA based upon classification. This applies to all entities that make, package, label, import, or export medical devices. There are three classifications: 1, 2 and 3. Devices are grouped into one of these categories based upon the risk associated with their use. The lower the risk, the lower the classification and fewer controls placed on the medical device by the FDA.

A Class 1 medical device is subject to what is known as general controls by the FDA. General controls are related to and include the following:

• Registration and listing
• Premarket notification
• Repair, replacement or refund
• Records and reports
• Good manufacturing practices

Nearly all Class 1 medical devices are exempt from premarket notification; however, the entity must be registered with the FDA and the product listed. This classification is reserved for devices that do not pose much if any risk to the patient or the user. Microscopes, stethoscopes, bedpans, and bandages are examples of Class 1 medical devices.

Developing PCBs for Class 1 Medical Devices

All medical devices, including Class 1, must adhere to the stringent regulatory oversight required to ensure patient safety and product quality and reliability. For PCB development, this means instituting good PCB design essentials and ensuring that you follow a design paradigm that ensures meeting all of the applicable standards. Chief among these are ISO 13485 and ISO 14971, which should guide the quality and risk management, respectively, for your board’s design and manufacturing process. Aside from meeting the regulatory requirements for medical devices, you should follow the development guidelines for safety, quality, and reliability shown below, as should be done for all classes of medical device development.

Guidelines for Class 1 Medical Device PCB Development

A. Design for safety

By far, the most important consideration that should be at the forefront throughout development is safety. The safety of the patient and/or user of your product should supersede all other design objectives. As a baseline, you should incorporate the controls for your product as set out by the FDA for Class 1 medical devices. Additionally, you should apply safety controls to protect against design data transfer breach.

B. Build for quality

In support of the prevailing prime directive of user safety, you need to follow steps to find a critical system contract manufacturer (CM) that is committed to building the high-quality PCBs that you require. This includes maintaining a risk management plan in coordination with your CM’s agile manufacturing capabilities to quickly address any threats to your product quality needs.

C. Test for reliability

Your PCB design and manufacturing should be guided by safety and quality concerns, but the final product also has to perform reliably. In order to gauge or predict reliable performance prior to distribution or delivery, adequate device testing must be performed. As Class 1 medical devices that are non-invasive, such as microscopes, may be used in laboratories or for analysis, their reliability is important. Incorrect readings or results could possibly lead to misdiagnoses and perhaps even an ineffective or dangerous treatment regimen.