Medical Device Contract Manufacturing
BihlerMED has well over a decade of experience in the design, engineering, development, and testing of medical devices. We offer best-in-class product design and manufacturing services and are a full service company that is totally committed to the safety & quality of medical devices. Learn about our medical device design process, see our comprehensive list of contract manufacturing capabilities, and review some of our product successes below.
Medical Device Contract Design Process
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:
- Medical Device Design
- Benefit-Risk Analysis
- FDA Paperwork, Requirements
- Design Verification
- Product Launch
We put extensive research and years of experience into every product we design and support, and the result is undeniably a better, more functional, and higher quality device. Contact Us with your design/development questions or to learn how we can assist you with your project.
Medical Device Manufacturing – The BihlerMED Advantage
While other device design companies outsource production to third party outfits, thereby reducing their supply chain presence and accountability, BihlerMED offers the unique advantage of dedicated in-house manufacturing facilities.
As an integral member of the Bihler Group of Companies, we have access to proven, technologically advanced manufacturing and assembly automation solutions for medical devices. Our clients enjoy peace of mind knowing our team is involved in every step of the project from design to manufacturing to distribution.
BihlerMED Manufacturing Capabilities include:
- Plastic Injection Molding
- Metal Stamping
- Documentation Processing (Small Scale Prototyping to Full Production)
- High Volume Production
- Packaging and Labeling
- Sterilization Coordination
- Sterilization Coordination
- Cleanroom IS0 8 & ISO 7
- FDA Submission
Contact Us for more information about our medical device manufacturing facilities.
Medical Device Innovation Leadership
BihlerMED provides the products that enable surgeons and medical professionals to perform procedures more quickly, more safely and with better patient outcomes.
Through our extensive testing we have developed and brought to market products like the ergonomic and reliable Scintillant® Surgical Light.
We developed the family of Scintillant surgical lighting devices to be compact, cordless and lightweight. This gives surgeons the ability to position the bright LED illumination precisely where it is needed, even in the tightest spaces, to help surgeons operate more efficiently and precisely.
BihlerMED has active and completed projects in a variety of device categories including:
- Intravenous (IV) Devices
- Dual Tip Surgical Lighting
- Medical Mouthpieces
- and more… (contact us)
Medical Device Lifecycle Partnership
At BihlerMED, our continuing mission is to design, engineer and develop advanced medical devices and accessories that “Make Healthier Happen.”
We are not simply a medical device contract manufacturer, we are your partner in the journey to either create your new device or to maintain & automate the production of your current device. We work with you every step of the way, from the genesis of the strategy through the legal and regulatory reviews, into the market, and post-market support.
We’d like to partner with you and help take your product from Concept to FDA/CE Approval to Production. Contact Us below or call 908-329-9123 to speak with a contract manufacturing expert today!
About The Bihler Group
BihlerMED is part of the Bihler of America family, a leading producer of precision high-speed metal stamping, forming, welding, tapping, molding, and multi-piece assemblies with worldwide partners. For over 40 years, Bihler of America’s success has been built on outstanding technology, training, quality, and a continuing culture of excellence. Our personnel receive extensive ongoing training and certifications in the most up-to-date processes and machinery.
Additionally, Bihler 4 Slide-NC machines take manufacturing technology to a new level of efficiency, reliability, performance, and productivity.