Consultant Medical Devices Regulatory/US Submissions Expert
Introduction
We are pleased to announce that Michelle Hasse joined Qserve as a Medical Device Consultant and Regulatory/US Submissions Expert based in the US.
Experience
Michelle focuses on US premarket regulatory strategy and submissions and has experience with products of all regulatory classifications, including radiological devices, electrosurgical devices, cryoablation probes, surgical mesh, and wearable monitoring devices. She is skilled in navigating complex regulatory landscapes and developing bench, animal, and clinical evidence-generation plans taking the least burdensome approach to meet unique situations.
Michelle, about working at Qserve
“It is an honor to join such an esteemed group of regulatory, quality, and clinical experts at Qserve Group. I look forward to helping manufacturers from across the globe navigate the FDA and gain market access for their medical devices in the United States.”
Before Qserve
Michelle has over eight years of experience in medical device regulatory and clinical affairs with many companies, from small start-ups to large international device manufacturers. She holds technical degrees in Biomolecular Engineering (BSc) from the Milwaukee School of Engineering and Biotechnology (MSc) from Northwestern University.
The key expertise areas of Michelle Hasse:
- Preparation of US FDA regulatory strategies and submissions
- Expert advice on regulatory pathway selection for traditional and novel medical devices
- Identification of potential 510(k) predicates and expert advice on predicate selection
- Preparation of FDA pre-submissions tailored to help clients get the best answers to their regulatory questions and FDA buy-in on proposed test strategies
- Provides advice on the best format for pre-submission meetings given the client’s needs and supports the client during teleconferences and in-person FDA meetings
- Extensive experience preparing IDEs, 510(k)s, De Novos, and Breakthrough Device Designation Requests
- Skilled scientific/medical writers can justify novel technologies from a regulatory perspective
- Regulatory review of design changes, including software, preparing letters to file as appropriate
- Regulatory planning throughout all stages of the medical device lifecycle
- Provides regulatory advice during product development and transfer to manufacturing
- Reviews design history files, device master records, and product design dossier/technical files
- Review of risk management processes and risk analyses
- CE marking support
- Device classification, CE mark regulatory strategy, preparation of technical files, and design dossiers
- Review and preparation of animal and clinical trial protocols, clinical report forms, and study reports
- Provides strategic input into clinical evaluation plans, review, and preparation of clinical evaluation reports, and post-market clinical follow-up plans
- Implementation of quality management system processes considering clients’ unique needs according to ISO 13485 standards and 21 CFR Part 820. QMS procedure updates to meet new jurisdictions, such as MDSAP country-specific requirements
- Regulatory review of labeling and advertising