Design and Prototyping
Have an idea, however, you aren’t sure where to begin? Let us help.
Our passion is helping companies move their ideas forward. We offer full-service design, strategic planning, and prototyping services. We can work with you to create a road map to get you where you want to be. Engineering and innovation are in our DNA, we think like you do. Our team uses the latest 3D Printers and offers services from prototyping to full scale medical device assembly and manufacturing.
When you work with us, your project manager is a Biomedical Engineer with experience and training in FDA and ISO Regulatory and Quality standards. This combination of skills helps them seamlessly work with your project team at all levels. We know the guidelines and we understand the engineering process and concepts and we can help you navigate and avoid obstacles before you even realize the obstacle exists.
Chat with us and let us help you execute your vision!
Product Development Plan Creation
Have an idea, but not sure where to start? Or don’t know if you can identify all the regulatory requirements for a project? Do you just need some help getting a project off the ground? Our team of medical device engineers have been successfully launching devices for more than 20 years. Let us help you understand the overall and detailed plan and how to get from day one to product launch with practical, business-focused insight and planning.Get in touch
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.Get in touch
User and Product Specification Development
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.Get in touch
Software Design Control Document Creation
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.Get in touch
Manufacturing Validation Protocol Development
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.Get in touch
Risk Management Assessment
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.Get in touch
Biocompatibility Testing Requirements
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.Get in touch
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.Get in touch
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.Get in touch
3D Printed Prototypes
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.Get in touch
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?Get in touch
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.Get in touch
Scanning a part and printing a replacement…..how cool is technology now? We focus on accuracy and speed of delivery.Get in touch
File Repair and Optimization
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.Get in touch
Have a question?
Should My Class I Device Have Design Controls?
Design controls are a set of processes and procedures that are used to ensure the safety and effectiveness…
When Do You Need an IRB?
IRB or Institutional Review Board is an FDA-approved group that’s responsible for monitoring any biomedical research or study…
Outlining the Design Control Process of Medical Devices
In the medical industry, Design Controls facilitate the structural and developmental process of medical devices, particularly Class II…