Engineered Medical Solutions DBA BihlerMed® proudly is ISO 13485:2016 certified.
Who We Are
BihlerMed® is an innovative leader in LED surgical light manufacturing, and in custom medical device manufacturing. As a member of the Bihler® Group of Companies, we can deliver technological solutions that draw on the vast repository of Bihler® knowledge and experience.
We provide services such as: research and
development, design and engineering, and testing, clean room packaging, sterilization coordination, in addition to manufacturing. Our trusted performance will enable you to meet the critical needs of the medical industry, and a wide array of applications.
BihlerMed® manufactures and supplies reliable, high-quality handheld surgical LED lights that are universally trusted by medical practitioners.
Worldwide Company- Local Citizens
We proudly manufacture all of our Surgical Lights at our state-of-the-art facility in Phillipsburg, New Jersey, where we are fortunate to have a highly-skilled local labor force. In return, we strive to maintain a small carbon footprint for our neighbors, and as such, we make extensive use of solar panels on the buildings in our facility.
BihlerMed® Medical Manufacturing
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:
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
High Volume Production and Automation
As an integral member of the Bihler Group of Companies, BihlerMED® has access to proven, technologically-advanced manufacturing and assembly automation solutions for medical devices. Our customers can enjoy peace of mind knowing that the BihlerMED® team is working beside them on every step of the project – from design, to manufacturing, to distribution.
The Bihler® systems are designed and built to meet the high-volume production needs of our customers, and to enable them to expand their production capacity rapidly, in order to meet the ever-growing demand for start-up and new-to-market medical devices.
45+ Years of Experience
Here at Bihler® and BihlerMED® we have teams dedicated to help you with your manufacturing needs.
- Part Design, Prototyping, 3D Printing and Prototyping Assembly.
- Injection molding, mold tool design, mold tool maintenance, robotic integration, cost-saving regrind, and scientific molding.
- Full in-house machine shop for metal and plastic fabrication, from milling, turning, and grinding, to Wire EDM and 5 Axis CNC.
- Electrical assembly includes PCBs, micro soldering, flexible circuitry, wiring, debugging, and innovative LED implementation.
- Metal stamping and forming capabilities of intricate precision components having tight tolerances.
- Multiple joining techniques – e.g., glue, screws, pins, heat set, UV-cured adhesives, and ultrasonic welding.
- Sensitive liquid storage, batch mixing, and precision volumetric filling.
- Hand and automated assembly of complex medical device components, with full lot control, from raw material to finished goods.
Bihler® is committed, through our apprenticeship programs, to sustaining manufacturing for generations to come.