ºÝºÝߣ

ºÝºÝߣShare a Scribd company logo
Personal Information
Organization / Workplace
Washington D.C. Metro Area United States
Occupation
Partner
Industry
Legal
About
In my law and consulting practices, I focus on government regulation of the medical devices and combination products, including FDA and Medicare. Within that space, I further focus on: 1. Regulation of health information technology, including mhealth --Regulatory assessments and 513g --Submission strategy --Quality systems 2. Medical device advertising and promotion, including --Health economic claims --Social media --Scientific exchange an unsolicited requests --ASR's and RUO’s 3. FDA regulatory compliance --Assessing need for recalls --FDA defense --Compliance remediation --Internal investigations 4. Combination products, and particularly drug delivery and personalized medic...
Contact Details

Presentations(2)Ìý

The Supplier Relationship
The Supplier RelationshipThe Supplier Relationship
The Supplier Relationship
Ìý
Business Model Elements
Business Model ElementsBusiness Model Elements
Business Model Elements
Ìý