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.

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.

Device Classification

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.

Data Analysis

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.

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.

Part Optimization

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.

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.

Project Management

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.

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.

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.

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.

Report Writing

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.

CAD Modeling

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?

Part Replication

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

Trial Management

Our clinical study management process is where scientific excellence converges with innovative technology to optimize clinical study management. With a steadfast commitment to advancing medical knowledge, our team of biomedical engineers specializes in orchestrating clinical trials with precision.

From crafting detailed and well thought out protocols to ensure rigorous study design, to navigating complex regulatory landscapes and upholding the highest ethical standards, we are your partners in driving forward groundbreaking research.

Our rigorous data management practices and unwavering commitment to quality assurance guarantee the integrity of your study's outcomes.

We are excited to collaborate with you on your project, working together to shape the future of healthcare.

Clinical Monitoring

When it comes to clinical monitoring, we’ve got you covered. Our experienced team members will ensure that your site research activities are properly recorded, conducted, and reported according to the study protocol, all while following the necessary regulatory requirements.

Data Management

Data management is a key part of the clinical trial process. A data management program should be in place to help with the process of gathering, managing, and analyzing data. We utilize Viedoc as our preferred data management program to provide you an all-in-one solution.

Biostatistics

Our team will help create a straightforward statistical analysis plan that will lessen the length of the project and keep things on track. Our technical knowledge and expertise are essential in interpreting the data gathered from clinical trials. We are much more cost-effective than an in-house biostatistician.

Medical Writing

We provide medical writing support for all stages of product development. We offer flexible and efficient processes for any size project. We apply best practices for content, format, and style to meet global technical and regulatory requirements.