Mary Kay Kessinger Sobcinski
Senior Director of Strategic Consulting
Avania
Talk to Mary Kay about these topics and more:
- MedTech clinical study strategy/design/planning
- MedTech regulatory challenges, strategies, and solutions
- Clinical studies for device-drug combination products
- FDA negotiations, submission prep, protocol generation, and clinical report generation
- FDA BIMO inspection prep, conduct, and support
Clinical Strategic Planning
Drug-Device Combination Products
FDA
Regulatory