Design, development, engineering analysis, and accredited testing from a team that works exclusively for the medical device industry.
We are biomedical engineers who have dedicated our careers providing innovative solutions to the orthopedic medical device industry.
We provide full-cycle engineering support for orthopedic implants and instrumentation. From initial concept and feasibility through CAD development, risk analysis, prototyping, and design verification, we provide the technical expertise your program requires.
We are ISO/IEC 17025:2017 accredited. We develop custom test protocols to ASTM, ISO, and FDA requirements, delivering documentation structured for regulatory submission. Capabilities include cadaveric evaluation, strain gage analysis, implant fixation testing, and biomaterials characterization.
We leverage finite element analysis to predict device performance and optimize designs prior to physical prototyping and testing. We validate simulation results through correlation with physical testing, ensuring predictions match real-world behavior.
Focus Medical Design and Development is accredited to the ISO/IEC 17025:2017 accreditation demonstrates technical competence and validated processes aligned with internationally recognized standards. Accreditation means test results carry weight with FDA and regulatory bodies worldwide. We test to applicable ASTM and ISO standards as well as published FDA guidance with flexibility for custom protocols when your device requires it.
Standards Compliance
Standards Compliance
Submission Ready
We structure partnerships around what your project requires. Customers can access a range of services including full design and development support from concept to market introduction including verification and validation and regulatory submission activities. There are also options to access targeted design engineering, testing or simulation services for more specific needs. Complex programs benefit from a single point of contact through project management across multiple workstreams. Whether you are a startup, OEM, or multi-national corporation, we can partner with you to attain your goals.