Our Concept-to-Customer process guides your medical device seamlessly from a nascent idea to a feasible concept, then on to final design, verified and through the regulatory process. Additional value is added as Proven Process is able to manufacture, manage any aftermarket issues the medical device may encounter. We take the time to thoroughly understand and properly specify the requirements of your device and design it with manufacturability in mind. Proven Process is structured to complete pilot and full-scale manufacturing demands, as well as clinical study design and management. Our fully-staffed Regulatory Assurance Group can handle all facets of FDA and EU regulatory submissions.
Guided by 20 plus years of medical device design, development and manufacturing experience, our medical device design capabilities accelerate your device's approval process. Our Product and Design Verification processes ensure your new medical device meets domestic and international standards.
From concept through design, product approval and production, our Proven Process provides transparency, collaboration and the assurance of on-time and on-budget market delivery.