RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.
Clinicians within a medical device company are often overlooked in the regulatory process. Manufacturers recognize the criticality of the clinician role in identifying and validating customer requirements and potential risks associated with device use. However, incorporating clinicians in regulatory affairs could also significantly increase the odds of product approvals by the FDA and notified bodies.
In this session, our panel of clinicians (including a neurosurgeon and anesthesiologist) will discuss ways that they work with Regulatory Affairs teams to improve outcomes for submissions, including the following and more:
- Scoping intended use/purpose and clinical indications (incorrect scoping is currently the biggest issue notified bodies are findings in IVDR submissions)
- Scoping state of the art from a physician's perspective, ensuring it truly represents what clinicians do on a daily basis
- Identifying clinical risks and mitigations clearly across risk, CER/PER and PMCF/PMPF documentation
- Clearly defining the clinical roadmap for ease of understanding and review
- Writing CERs/PERs that are comprehensive and will withstand review by clinical experts in regulatory authorities
- Responding to post market surveillance challenges
- Reviewing claims and guiding responsible marketing
- Being part of cross-functional teams from device development through the entire device lifecycle
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Sally Sennitt, MBBS, FRCA – Medical Director RQM+
- Andrew Tarnaris, M.D. MD(Res) FRCS(NeuroSurg) – Medical Director
- Dulciana Chan, M.S.E. – Principal Consultant