Manufacturing
Engineered Medical Solutions DBA BihlerMed® proudly is ISO 13485:2016 certified.
46+ 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.
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:
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.
