Heather is a consulting professional with 15+ years of experience in global project management, operations management, budget/grant/contract management ($25M+), change management, line management, strategic planning, training development, protocol development, phase II-IV pharmaceutical development, class II-III medical device development, audit preparation & execution, clinical trial regulatory compliance, ICH good clinical practice, and CAPA development and implementation. Heather is an expert at grasping complexities and absorbing large amounts of information to make big picture decisions that are aligned with standard operating procedures for project goal realization. Heather has worked with a broad array of companies including start-ups and global medical device and pharmaceutical companies. Very few people in the industry have the breadth and the depth of experience in clinical affairs that Heather has. Heather can help you create and execute strategic plans for the clinical affairs challenges you are experiencing and provide risk mitigation practices that will prevent future challenges.
- Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
- Final US FDA Guidance on Post-market Cybersecurity Risk Management
- ISO 13485:3026
- Due Diligence and QMS assistance
- Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)