Navigating the medical device product lifecycle from concept to commercialization is an exciting journey. Our goal is to put safe and effective devices in physician’s hands, so that they can treat patients. We can help you move your project from one phase to the next, bringing your idea closer to its realization. We’ve 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 commercialization in view.
We collaborate with you wherever you are in the medical device development process. Our engineering team has history and experience with upfront feasibility R&D, including acceptance criteria development and material level testing, formal verification and validation testing that is needed for global regulatory submissions, and post-market competitor evaluations for claims. Our 13 year history of ISO IEC 17025 accreditation has given us assurance that our efficient and 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 testing and engineering experience including design controls and validations, testing to support regulatory deficiency question responses, clinical case support and physician training on proper delivery of a wide range of devices. Some areas in which we have experience testing devices include but are not limited to: