Lora is a consulting professional with over 11 years of experience in process and product engineering, commercialization, project management, regulatory and operations/quality management. She has a proven track record of successful medical device product launches for cardiovascular, neurovascular, and orthopedic markets. Lora’s long list of skills includes CE Marking, FDA submissions, Quality Assurance Audits, Risk Management, and program management for product commercialization.
- 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)