BihlerMed® is an ISO 13485:2016 Certified company, where 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:

Prototyping: Our team of experienced mechanical and electrical designers, using 3D printing, has the capability for rapid design iteration, from visual representations to fully functional prototypes for clinical trials.

Product Design: Our Engineering Team has experience bringing a vast array of medical devices from concept, to reality, to market. With our primary focus on surgical lighting, BihlerMed® has developed an untethered LED illumination device, and has patented the technology necessary to bring the device to market. As a contract manufacturer, we have extensive experience defining design inputs, compiling DHF and DMR, performing Risk Analysis/Mitigation, and assisting our customers with their FDA 510(k) 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