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Areas of Expertise

Develops most efficient FDA and international product registration strategies, development plans, and provides scientific support. This includes:

• Premarket Approval Applications (PMAs) and Premarket Notification Applications (510(k)s)
• Targeted medical device strategies and requirements
• Conformity Assessment Documentation for European registration
• Investigational Device Exemption Applications (IDEs)
• Meeting with FDA and European Agencies to determine appropriateness of plans
• Provides marketing and reimbursement strategies
• Designs and analyzes post-marketing surveillance programs, studies, and registries
• Performs corporate due diligence work for acquisitions and product development and stewardship
• Helps clients to achieve quality assurance and compliance with FDA and international standards

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