Design and Prototyping

Utilizing our proven Product Development Process or your internal product design process, our experienced, Biomedical Engineer project managers can guide your project team from day one to product launch. Each of our project managers has led multiple successful Class I and Class II projects to market and we understand all aspects of product development. This real world, practical experience and total process understanding leads teams to obtain goals in a timely manner with successful results.

FDA and ISO both require user and product specification development, an important step ensuring the development team understands the requirements for the product. Our team of medical device engineers understand the practical and regulatory aspects of this process, and we can help lead your marketing and development teams to establish concise, well written, and easily understood requirements and specifications. Starting projects on the best footing is important, let us help.

Software as a Medical Device (SAMD) has different requirements and needs from standard hardware type device development. Our team of experts understands the regulatory requirements and the documentation needed. We are ready to help your software developers create submission ready documents to move your project from code to launch.

Our team of medical device engineers can help you develop effective validation plans, protocols, and, ultimately, successful results. We have experience with 3D manufacturing, laser processes, cleaning processes, and even complex software validations.

No time to prepare and document a comprehensive Risk Management Assessment? We can work with your team to prepare and conduct a risk-based assessment. Utilizing the latest standard (ISO 14971:2019) and our years of professional experience, our team can either provide support for your team or completely undertake the project independently.

Not sure what the regulators want to see for Biocompatibility testing? We can work with your team to help understand all the various guidance documents (FDA, ISO 10993, e.g.) and how to apply them to your product to assure a safe product and practical mindset.

Do you have an overwhelming amount of data from a test? Or do you just have too much to do and not enough time to organize, analyze or synthesize data from a test? Let us help you move your project forward. We have PhD level medical device engineers with years of experience conducting, analyzing, and assessing testing data, and statistical resources to make the data understandable and useful to your team. We can compile all your data into a report with recommendations and conclusions as needed.

Do you have a team of talented engineers whose time is monopolized with writing reports to satisfy regulators when they could be working on new, innovative projects? Let us help you free up some resources. We have a team of technical writers and medical device engineers, who work together to create solid, professionally written documents for your projects. Hand us the data and we will prepare the report.

Do you need a fast prototype to show your investors? Potential Customers? Sit down with one of our designers and we can craft a 3D prototype and produce it at an affordable price.

Our designers can create CAD models of your designs. We take your vision and render it in 3D. Pictures are worth 1000 words; is a 3D picture worth 3,000 words?

We can quickly create 3D printed parts so you and your team can continue to optimize the design without the costs of injection molding and casting.

Scanning a part and printing a replacement…..how cool is technology now? We focus on accuracy and speed of delivery.

Our team of talented designers can help optimize your current 3D files and make them easier to 3D Print and save your team money and time.