Medical Device Design
At BihlerMED, we believe in a comprehensive design/development process that combines the highest levels of technical engineering and R&D with the assurance that the final product will meet all applicable regulatory standards. The result is a medical device that is safe and effective for your application.
BihlerMED Design and Development Services include:
- From visual representations to fully functional prototypes for clinical trials, we have a team of experienced mechanical and electrical designers and 3D printing capabilities for rapid design iteration.
- From concept to reality, our Engineering Team has experience bringing a vast array of medical devices to market.
- Primarily focused on surgical lighting, BihlerMED developed an untethered LED illumination device and patented the necessary technology to bring such a device to market.
- As a contract manufacturer, we have experience defining design inputs, compiling DHF and DMR, performing Risk Analysis/Mitigation, and assisting our customers with their FDA 510k and De Novo Submissions.
In house testing/validation
- We develop and execute IQ/OQ/PQ Validations for self-designed equipment and processes to meet customer demand.
- Full-design verification and validation activities include scheduling and oversight of third-party testing to meet IEC and ISO standards.