Regulatory Planning Services
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| With 20 years of medical device experience, Ms. Bannick has:
- developed and executed Domestic & International Regulatory Strategies.
- prepared and submitted US submissions: PMAs, IDEs, and 510(k)s.
- compiled international dossiers, including onsite presentation to TuV Munich as well as Canadian, Japanese and Latin American submissions.
- coached teams for FDA Meetings, including on-site presentations.
- prepared teams for panel meeting, including "mock" panel meetings
- served many roles in Project Development Teams
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| 3701 Munkelwitz Rd., Isle, MN 56342
office: 320-676-1440 fax: 320-676-1444 cell: 320-630-5171
Contact Karen at karen@bannickconsulting.com
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