FDA | Medical Devices | Regulatory Affairs | Strategy

Regulatory Intelligence & Strategic Education

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What is MedTech RISE?

A medtech consulting firm transforming regulatory intelligence into educational and actionable strategy for professionals and businesses.

You’ve read regulations, guidance documents, and excellent regulatory intelligence briefing emails. You’ve seen the webinars.

MedTech RISE helps you make it practical.

Discover our services

Explore this option if:

  • You need support interpreting medical device regulatory requirements and how to apply them to your business.

  • You need a thought partner for updating your strategy as federal regulations and guidance change.

Explore this option if:

  • You desire training that frames regulatory requirements in the context of your specific device area.

  • You or your team are new to medical devices and want to understand regulatory affairs fundamentals in laymen’s terms.

Explore this option if:

  • You have a medical device idea or product in early stages of development and want to prepare to bring it to the U.S. market.

  • You need someone to partner with you in creating a roadmap to meet U.S. regulatory requirements.

Anike K. Freeman

Founder & Principal

Anike’s 15 years of medical device regulatory experience includes FDA service, industry regulatory affairs, and consulting. She brings stability to MedTech teams and businesses as a strategic, resourceful, and temperate leader.

Contact Us

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