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The First Pillar of Quality Engineering for Medical Devices

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One aspect of REV.1 Engineering that sets us apart from many product design firms is the experience we have working within medical device quality systems. With years of experience at companies such as Abbott Vascular, Boston Scientific, Edwards Biosciences, Volcano/Philips, and many start-ups, our engineers and technicians understand how to work efficiently while still following necessary design controls. While we let quality medical device engineering guide our thought process, we do not let it become a constraint to delivering our clients solutions 2x Faster.

Sometimes, our clients are not as familiar with the quality systems used when developing medical devices. So we thought it would be appropriate to run a few blogs explaining what we refer to as: The 3 Pillars of Quality Engineering for Medical Devices.

Let’s start with the first pillar: Pillar 1: Design Control

The basis for design control is a solid design process. At REV.1 Engineering, our process is steeped in our proprietary project management system, which is customized for each client.

Risk is assessed throughout the development process by analyzing each feature that is part of the design. A failure modes and effects analysis (FMEA) matrix is created that lists all the different components, cross-hatched with all the potential failure modes, their effects and proposed risk control measures.

FMEA creates an analysis platform for a comprehensive risk management plan. This highlights where risk control measures need to be taken, and ultimately a risk management report is generated with specific plans to address any high risk features or materials and if needed a risk/benefit analysis.

The next critical part of design control is a verification & validation plan. Each step requires documentation of design inputs and outputs. Then a test plan must be developed that adequately exercises the device. Product claims (such as catheter flow rate or burst pressure of a balloon), along with anything that can come apart, must all be tested, so a thorough plan is essential to successfully creating a commercial-viable medical device.

Test plans will include bench testing and pre-clinical testing. Various environments must be included in the testing, in order to simulate the “real world” environment in which the device will be used. For example, a device that will be used in an artery is exposed to completely different set of stressors than one that will be used in the acidic environment of the gastric system.

Sterilization validation is an important part of preparing for commercialization. How does the product need to be packaged and sterilized? Gamma radiation, e-beam, gas? How will the product need to be shipped in order to maintain sterility?

Once a product is in circulation, directions for storage, aging, and usage are needed. Shelf-life/Time zero functional testing provides documentation to back up product shelf-life claims as well as instructions on safe storage practices. The FDA also requires a report on useability protocol, delineating human factors and the effects of both expected and unexpected usage over time.

In addition to FDA and/or CE Mark product approval, design transfer and process validation are the final key phases to successful commercialization of your medical device. Working closely with the chosen manufacturer, whether internal or external, each element of the design must be clearly detailed to ensure precise implementation of the design in large-scale replication.

Once the manufacturer has developed the assembly processes based on the design, those need to be validated. The repeatability of the equipment must be verified, and the processes must be tested under both high and low operating conditions. The goal is that on any particular day, with any particular operator, the medical device will be properly and consistently assembled, packaged, sterilized, and prepared for shipping.

Join companies like Topera and Ablative Solutions that have worked with REV.1 Engineering to successfully execute their entire design control process, resulting in FDA approval of their medical devices. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at, and let’s implement your medical device design to move you toward FDA approval – 2x Faster.