RBC can help you – on target, on time, and on budget.
Medical device project management and design starts with structure but also many questions.
Medical Device Design & Development Services
- What is the intended use of the medical device?
- What intellectual property and technology is available for this medical device innovation?
- What do market, user, and patient experience say about the problem you seek to solve with your medical device?
- What are business and design risk factors?
- What are the regulatory considerations?
- Is there a predicate device and a path for FDA 510(k) clearance? Will we seek CE mark certification?
- What prototypes (preliminary or otherwise) will be needed for marketing, clinical, engineering, certification and other purposes?
- Are there any special supply/sourcing considerations?
- What are the estimated volumes for manufacturing?
- Most importantly, how will you define project success?