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.

• Medical Device Design
• Design History File (Creation and Maintenance)
• Prototyping
• Packaging Design and validation.
• Benefit-Risk Analysis
  
• FDA Paperwork, Requirements Submission
• Design Verification and validation including: Biocompatibility testing, user needs and benefit-risk analysis
• Product Launch
• Design for Manufacturing, and Process & Tooling Development

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.