Specializing in Class II and Class III Medical Devices
At Proven Process, exceptional medical device development and manufacturing is our exclusive focus. As an experienced Class II device and Class III therapeutic and diagnostic device contract R&D and OEM manufacture provider, we provide clients with expertise in Mechanical Engineering Design, 3D Device Modeling, and Design Analysis, Electrical & Electronic Engineering, Software Development, Verification and Validation, and OEM Manufacturing. We specialize in electromechanical devices including active implantable devices. Some of the implants we have developed include heart assist pumps (LVAD's), drug delivery pumps, blood pressure monitors and pacemakers. Our staff is expert in the design and development of electronic systems that meet all domestic and international safety requirements. Other capabilities include manufacturing; process validation; process QC; product design; product R&D; prototyping and rapid prototyping; software development and validation and FDA submissions.
Our customer-centric focus ensures that our customers get what they want and need from outsourcing, including: Cost Savings: We offer expanded capabilities and capacity immediately, without the costs of hiring/training a full-time staff, adding expensive product R&D capitalization costs, or reassigning your valuable personnel from current projects. Reduced Product Time to Market: Proven Process focuses intensely on your project with resources tailored to your needs. These operating efficiencies translate to a faster turnaround. Reduced Development Cost: Using our product development resources, only when you need them, reduces the overhead associated with hiring full-time development staff. It also reduces the money lost by taking your valuable personnel from the work they are already doing to solve problems for which they may not have the experience. Flexibility: Outsourcing design, development, validation, and manufacturing needs to Proven Process gives you the flexibility to assign your valuable product development resources where you need them the most. Focus: Letting us focus on the details of your new product development and validation allows you to focus on the broader business issues.