What Are the Medical Device Contract Manufacturing Requirements?

September 16, 2019 , in Blog, Medical

Father’s Day is one of my favorite holidays. I imagine the fact that I am blessed with a great dad has a lot to do with it. However, I also am grateful for having the opportunity to try and live up to that tradition. One of the things that my father always emphasized was that you should always try to do your best at whatever activity you were involved in and that you should expect to be able to perform as well as anyone else, given similar circumstances. As a father, I combined this mantra with a saying by a popular TV host from my youth, Casey Kasem. He would always end his show, America’s Top 40 by saying “Keep your feet on the ground and keep reaching for the stars."

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Combining these two sayings led to my fatherly advice that you should always stand upon a strong foundation or baseline and yet continuously seek to do better (your best). Basically, this means that even at your worst, you are meeting the baseline requirements of the task. However, your goals and expectations should always be to rise above that level. This advice can be readily applied to most endeavors, including the development of PCBs for medical devices.

PCB development or the designing and manufacturing of circuit boards for medical devices have minimum regulatory requirements and standards that must be met. Failing to meet this baseline will likely mean your product will never be sold as the medical industry goes to great lengths to ensure that subpar products are not utilized. The quality of your medical device is directly linked to the operations of your contract manufacturer (CM). Therefore, your ability to meet and exceed the minimum requirements depends upon the medical device contract manufacturing requirements placed upon your CM. First, let’s see what your minimum expectations should be and then look at how an optimal level can be reached.

The Minimum Requirements for Medical Device Contract Manufacturing

The medical devices industry is probably the most regulated product industry. There are standards and guidelines for every aspect of development and even post-production monitoring is required. The level of restriction and which specific regulations apply are determined by whether your medical device is categorized as class 1, class 2, or class 3, with constraints increasing as classification level does. All classes must adhere to ISO 13485 and ISO 14971 standards for quality management and risk management, respectively.

ISO 13485 lays out how your quality management system should be structured and includes the following provisions [1] that impact your medical device contract manufacturing requirements:

  • Product realization planning
  • Design and development
  • Purchasing process
  • Production
  • Monitoring and measurement

Similarly, the ISO 14971 standard describes and details how to generate and execute your risk analysis plan [2], which includes requirements for your CM’s manufacturing of your medical device board.

ISO 13485 and ISO 14971, along with IEC 60601 that provides safety requirements for electrical medical devices and US FDA 21 CFR Part 807, which requires registration of all entities involved in manufacturing or distributing medical devices, provide the minimum requirements for the manufacturing of your medical device. However, this does not ensure the best or optimal building of your medical device PCBs.

Optimal Medical Device Contract Manufacturing Requirements

Although simply expecting your medical device contract manufacturing to minimally meet the industry’s regulatory requirements will likely result in a marketable product at some point, it certainly will not result in you being able to successfully compete in an industry like medical devices. This industry not only supplies some of the most scrutinized products but is also driven by innovation and new technology. Thus, developers are constantly challenged to not only improve product performance but also how products, electronics, and PCBs are made.

These challenges cannot be met by meeting minimal medical device contract manufacturing requirements. Instead, the building of your medical device boards needs to be optimized. This begins with understanding and implementing essential keys into your medical device development to ensure your medical device meets or exceeds industry standards and user needs, and is built as efficiently as possible. Meeting these higher standards depend upon your medical device contracting manufacturing requirements, which should include the following:

  • Transparency

In order for the building of your boards to fully reflect your design intent and make the best use of DFM, your CM and you must have open communication about the design and the manufacturing process.

  • Commitment to quality

Safety and reliability, or in a nutshell, quality must be the overarching goal of your development process. You should require that your CM exhibit this commitment by certifications and experience.

  • Supply chain security support

Due to the safety requirements for medical devices, being able to secure the supply chain and trace all components is critical to prevent breaches such as counterfeit components.

  • Documentation control

Another sensitive area of medical device development is maintaining strict control of records and documentation. This includes design, component procurement, testing, and other data that your CM will most likely create or be privy to.

  • Agile manufacturing process

The medical devices industry continually sees new technological advancement and experiences changes in equipment performance specifications. These and other change requests necessitate that your CM’s equipment and processes be agile enough to quickly respond without loss of quality.

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  • Works with 4 of the top 10 medical devices manufacturing companies.
  • ISO-9001, IPC-600 and IPC-610 commitment to quality certifications.
  • Accurate quote in less than a day.
  • DFM support from Day 1 of design.
  • Fastest turnkey PCB manufacturing in the industry.
  • Rigid, rigid-flex and flex board capabilities for wearables and embedded biosystems.
  • Custom automated BOM verification tool.
  • Sources components from the most reputable suppliers in the industry.
  • Software-driven robotics assembly.
  • Standard quality testing, including X-ray and inline AOI.
  • Superior open, transparent PCB manufacturing experience.

At Tempo Automation, we are not minimalists. We have the PCB industry’s fastest prototyping and low volume process for building high-quality boards. We employ an open, transparent white box approach to PCB development that allows our software-driven process to quickly institute changes when necessary with low to no impact on turnaround times and board quality.

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 CAD files or how to incorporate your design into a CAD format, contact us.

[1] Please see the ISO 13485 standard for specific guidelines and required actions.

[2] Please see the ISO 14971 standard for specific guidelines and specific actions.

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