Regulatory strategy for medical devices

Regulatory…

Clinical trials can happen any time during a product’s life-cycle, for example:

Human safety tests might be conducted during the prototype phase,

Feasibility, pilot, or manufacturing studies might happen during the pre-pilot phase,

Pivotal studies usually occur during the pilot phase,

Post-market surveillance, post-approval studies, registries, or marketing studies usually happen during production phase, but

Pivotal studies may occur during the production phase to add new indications for use.

Studies are regulated differently depending on when they occur. They’re regulated differently depending on the complexity or newness of the technology. Some studies need FDA approval or Competent Authority notification, some don’t and some are not regulated at all. We have experience from pilot to pivotal, disposables to implantables, IRBs to IDEs, 510(k)s to PMAs. We can help you meet the necessary regulations, without unnecessarily over-doing it.