Medical Device Engineering

Engineering with clinical and regulatory insight.

Our medical device engineering team offers a range of services to address your product development needs. Navigating the medical device product lifecycle from concept to commercialization is an exciting journey. Working through global regulatory bodies (FDA, NMPA, PMDA) and their unique requirements is common practice for our engineering team. Our goal is to put safe and effective devices in physician’s hands so they can treat patients.  We can help move your project from one phase to the next, bringing your idea closer to realization. We have learned along the way, the more quality work you complete on the front end, the greater likelihood of success in later stages of development. We use first principles of engineering to help move devices through the medical device development process, with the end goal of a successful exit or commercialization.

We collaborate with you wherever you are in the medical device development process. Our engineering team has experience with early feasibility R&D, including acceptance criteria development and material level testing, formal verification and validation testing for global regulatory submissions, and post-market competitor evaluations for product claims. Our ISO 13485 certification and 16 year history of ISO/IEC 17025:2017 accreditation has given us assurance that our quality system is robust and our reporting is efficient. Our well thought out reports will help you demonstrate how your medical device meets quality and safety standards. Our test reports are accepted by regulatory authorities globally.

We have medical device engineering experience, including design controls and validations, testing to support responses to regulatory deficiency questions, clinical case support and physician training on proper use of a wide range of devices. Our experience with medical device engineering covers the following technologies and clinical targets:

• Orthopedics
• Biologics
• Women’s health
• Cardiology
• Urology
• Endoscopy
• Endovascular

Did you know MED Institute …

• Has worked on several first to market products from concept through regulatory approval?
• Has created complete design controls for several Class II and III medical devices?
• Can assist you with acceptance criteria development, cadaver studies, model development and design control assistance?

Key Activities

Medical device engineering, R & D, Concept Development, Prototyping, Regulatory Strategy (FDA)