Defining robust clinically relevant acceptance criteria and boundary conditions can be a significant hurdle in the medical device development process. The clinical environment can be complex and highly variable. We have developed the acceptance criteria and clinical conditions for hundreds of devices in a wide range of clinical environments. Our efforts have helped produce medical devices that successfully stand up to their intended use and the requirements for regulatory approval.
Medical Device Engineering Services
Engineering with clinical and regulatory insight.
Navigating the product development path from idea to approved medical device is an exciting journey. The medical device development community can all agree that the ultimate goal is to put the best device in a physician's hands, so they can treat patients. We all want to improve a patient's medical treatment; this is both satisfying to our engineers and engrained in our culture. The experience of the MED engineers 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 better 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.
Every medical device needs to be tested to assess its safety. When your project comes into MED, we look at it as a whole. We listen to our clients needs while considering the clinical, scientific, regulatory and engineering perspectives before work begins. MED's experience helps you determine what tests are needed to properly evaluate your device. As we like to say, a good test is worth a thousand words and a bad test can cost many thousands more.
We collaborate with our clients wherever they 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 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:
• Women’s health
• Vascular stents, grafts, wires and other accessories
• IVC filters
• Heart valves
• Vascular and endovascular grafts