Even a genius needs a wingman℠

From an opportunity analysis of a new medical device concept to the nuts & bolts activities of product research & development, the Medavise® Med-Tech Consulting Group can help entrepreneurs, start-ups and growing companies bring their device ideas to life.

Success: starting at the beginning and focusing on the basics.Learn More
Ensuring success by using valid evidence to tell the story.Learn More
A strong quality system is the foundation of lasting success.Learn More

Meet Our Team

Britt NortonPresident & Founder
Britt uses over 35 years of experience in the medical device arena as an engineer, inventor, executive and entrepreneur to provide clients with results that have an immediate impact and enable long-term success. The pragmatic, evidence-based approach he applies to every project is drawn from his extensive background in R&D, Operations, Regulatory, Clinical and Quality Management areas. Britt holds a BSChE and an MBA, but is constantly learning from the experts that make up the Medavise team. Britt founded Medavise to help clients through the vast maze of medical device development.
TaraEngineering, Regulatory Support
Tara’s work in R&D and Project Engineering spans 23 years in start-up, mid-size and Fortune 500 medical device companies. While the detail work of product engineering, test development and data analysis are second-nature to Tara, her ability to see the impact of these details on the overall project scope gives our clients the edge they need to achieve success. Tara holds a BSChE, and her work with Class I, II and III devices has led to an issued US patent and successful regulatory approvals in the US and in international markets. Tara has authored multiple Clinical Evaluation Reports to the rigorous MEDDEV Rev 4 guidance.
SaraEngineering, Regulatory Support
Throughout her 14 years of experience in R&D, Manufacturing and Process Engineering, Sara has successfully led cross-functional project teams and their related budgets, schedules and hurdles. She holds BSChE and MMSE degrees, is an inventor on three issued US patents and her work on Class II and Class III medical devices has ranged from product and test development to complaint investigation and regulatory support. Sara’s advanced training in Manufacturing Systems Engineering is key to helping clients transition their products from development to production.
CarrieQuality Management
Carrie has over 20 years of experience as a quality assurance, regulatory affairs and project management professional in the medical device field. She holds BA and MS degrees and is an ASQ Certified Quality Auditor with additional training as an ISO 13485 lead auditor and in U.S. and international regulatory affairs. Carrie has helped many small medical device companies successfully implement paper-based and electronic quality management systems. Her expertise and attention to critical detail ensure that the quality system becomes a key component in a client’s success.
DebRegulatory Affairs
While Deb has spent most of her 32-year career as a Regulatory Affairs professional, she started out using her BS in Biochemistry as a scientist, engineer and inventor, which resulted in two issued U.S. patents. She has held critical roles working with the U.S. FDA and EU Notified Bodies in acquiring and maintaining regulatory approvals and clearances for interventional and implantable devices. Deb is committed to the use of regulatory best practices, and is as comfortable developing global regulatory strategies as she is in executing specific product registration and approval activities.
DaveEngineering, Regulatory Support
Most of Dave’s 34 years’ of engineering and executive experience have been devoted to product development of every class of device in urology, laparoscopic surgery and iontophoretic drug delivery. He is a licensed Professional Engineer with Bachelor’s degrees in Physiology and Mechanical Engineering and is an inventor on 15 issued U.S. patents. Dave has combined his technical expertise with his communication skills to become an expert in preparing successful NIH-SBIR grants and other critical technical documentation, including Technical Files, Design Dossiers and Clinical Evaluation Reports.
SabithaClinical Science, Regulatory Support
Sabitha’s career began in academia, spending four years in biochemical and genetic Post-Doctorate research. She has since led a Clinical Research Department, overseeing all aspects of clinical studies in the U.S. and Europe for a Class III implantable device, and has experience supporting PMA submissions. Sabitha holds a Master’s degree and a PhD in Genetics, is certified in Bioinformatics, and is an author on numerous peer-reviewed articles and conference presentations. Sabitha is a skilled technical writer, from drafting manuscripts to preparation of Clinical Evaluation Reports.

The Medavise team includes additional engineering, regulatory and quality system professionals to ensure your needs are met.

Contact Us

Medavise, LLC
8725 Columbine Rd. #44952
Eden Prairie, MN 55344
612.405.4059

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