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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:

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.

Clean Room 

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

Sterilization Coordination 

  • BihlerMED coordinates with multiple outside vendors for EO sterilization, and we are capable of meeting any of your sterilization needs through our many strategic partnerships.

We bring years of experience to every product we design and support and, and when that experience is combined with our extensive research efforts, the result is a medical device that is of unquestionably high quality and functionality. We encourage you to Contact us with your design/development questions, and learn how we can assist you with your project.

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