The path from concept to commercialization is a complex process. Developing medical products in this highly regulated environment is a challenge and requires a deep understanding of the various protocols and current regulations of the FDA and other agencies.
Sunrise Labs has prepared an outline of the medical device commercialization process as an overview of the business, development, and regulatory efforts required.
A Systems Approach for efficient and compliant design and development of Medical Devices
This whitepaper outlines how to evaluate technology readiness for new concepts, and offers methods to improve the odds for successful commercialization.
This whitepaper outlines how systems engineering can contribute to achieving greater success in completing complex medical device development programs.
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