Corvus Engineering provides unique expertise in the Medical Device industry. We provide design and engineering consulting for medical device development. We focus on innovation, problem solving, risk mitigation and regulatory concerns specific to medical device development. Whether you have a napkin sketch or already the process of developing a medical device, we have the expertise to help in the following categories among other: Orthopedic implants, extremities, sports medicine, total joint replacements.
Our group of medical experts have a process for bringing products from sketch to regulatory approval with our 5 phase process:
- Project Feasibility: Competitive Benchmarking and regulatory pathway analysis, design requirements
- Product Design: DFMEA, CAD modeling, Functional testing, design iterations
- Product Verification: Test Protocols, carry out Testing, 510(k) preparation
- Product Validation: Cleaning and Sterilization Validations, Lab testing
- Regulatory Submission: 510(k) submittal