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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:

Prototyping 

  • 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.

Product Design

  • 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.

 

Clean Room 

  • BihlerMED has a brand new modular 2,000+ sq.ft. cleanroom space, offering both ISO 8 and ISO 7 classifications in our Phillipsburg, NJ facility with room for growth and expansion.
  • Quality Engineering resources are available to define inspection criteria and provide continuous support with inline testing to ensure the highest level of quality and safety.

Sterilization Coordination 

  • BihlerMED coordinates with multiple outside vendors for EO sterilization and is capable of meeting any of your sterilization needs with our strategic partnerships.

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.

 

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