Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements vary greatly by country and potentially overlap and benefit one another. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start-ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time.

• This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

Creator

• Hammond, Matthew William

Publisher

• Worcester Polytechnic Institute

Identifier

• E-project-040813-164414

Advisor

• Schaufeld, Jerome
• Hoy, Francis

Year

• 2013

Sponsor

• Martin Sklar

Date created

• 2013-04-08

Resource type

• Major Qualifying Project

Major

• Management

Rights statement

• In Copyright