I must admit that I am a bit of a movie buff. I especially enjoy the early Hollywood movies when the actors and actresses were truly larger than life stars. One of the many things that intrigue me about these films, however, is not as much that doctors always carry a black bag, but that you never really seem to get a look at the contents. Notwithstanding the obligatory stethoscope, which seems to always emerge, it is as though access to the devices, data or information inside of the bag is to be controlled. These days, doctors no longer make house calls and have pretty much given up carrying black bags, as well. However, control over medical data and information persists.
Doctor’s black bag
One particular area where oversight is asserted is medical design data. There are obvious reasons why secure medical design data transfers are needed, such as preserving the PCB component supply chain. Even though medical design data must be secured from potentially unscrupulous individuals and entities, it must also be completely accessible and detailed for those with a need to know. Let’s take a look at how to control your design data and then enumerate a design transfer checklist for medical devices to ensure control is maintained throughout your board’s development and production.
How to Control Your Medical Device PCB Design Data?
The development of all PCBs categorized as class 2 and class 3 medical devices are subject to design controls as stipulated by the USFDA under CFR 21 Part 820. These controls also apply to certain class 1 devices; however, these typically do not include electronics and circuit boards. This regulation, as defined in section 820.30, is quite broad and applies to every aspect of medical device development. It is implemented by the creation, maintenance and release by approved signatories of documentation for each of the following:
Design Control Documents
- Design and Development plans
- Design Input requirements
- Acceptable Design Output
- Design Review procedures
- Design Verification procedures
- Design Validation procedures
- Design Transfer specifications
- Design Changes procedures
In addition to the documents listed above, a design history file (DHF) must be created for each medical device type. The DHF should contain or reference all necessary data and information that establishes the device development was done according to the standard. All of the control documents listed above must be approved by signature as to accuracy and completeness. For medical device PCBs, only the design transfer specifications cannot be verified in-house as they must fall within the equipment capabilities and expertise of your contract manufacturer (CM) to be buildable. In the following section, guidelines to ensure that this design control stipulation is satisfied and your board is manufacturable are presented.
Guidelines for Medical Device Design Transfer
The complexity of most medical device PCBs dictates that two levels or stages of manufacturing will be required. The first stage is prototype manufacturing, which is a part of an iterative process to maximize design quality. The final stage is production, typically low-volume, where the objective is to maximize the yield rate. For each of these stages, transfers of the design must adhere to the control standard. To aid you in making sure this requirement is met, as well as for the efficient building of your medical device PCB, it is advisable to follow a checklist, such as the one below.
A Design Transfer Checklist for Medical Devices PCB Manufacturing
You should ask and be able to answer the following questions prior to submitting your design package for prototype manufacturing and/or production.
- Are all components from registered sources?
- Do your DRC rules fall within your CM’s DFM guidelines?
- Does your design file package match your CM’s requirements?
- Is the method of design transfer secure?
- Will your CM create necessary documentation to support your adhering to the requirements of FDA CFR 820?
If you can check off all of the boxes in the list above then your medical device design transfer and development will satisfy the regulatory requirements of the FDA. At Tempo Automation, we are not only certified to meet medical device standards for quality, such as IPC-13485, but are committed to working with you to aid in your compliance to all applicable standards and to deliver the highest quality PCBs fast, including highly complex designs.
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And to help you get started on the best path, we furnish information for your DFM checks and enable you to easily view and download DRC files. If you’re an Altium Designer or Cadence Allegro user, you can simply add these files to your PCB design software. For Mentor Pads or other design packages, we furnish DRC information in other CAD formats and Excel.
If you are ready to have your design manufactured, try our quote tool to upload your CAD and BOM files. If you want more information on the PCB design transfer checklist for medical devices, contact us.