Medical Alley Association
Medtech Post-Market Essentials: Unpacking MDR/IVDR requirements, compliance strategies, and the responsibilities of regulatory and quality teams
December 8, 2022 | 10 AM CT
Post-market surveillance planning and reporting is a new motion for many medtech regulatory affairs teams. Unclear and inconsistently enforced requirements have allowed companies to support a wide range of approaches. The transition to EU MDR/IVDR regulations, however, has brought many of these vague requirements into sharp relief.
Medical device and in vitro diagnostic manufacturers who sell within the European Union are now required to maintain robust post-market surveillance systems and submit periodic safety reports to notified bodies and other regulatory authorities. Adapting to meet these new requirements will require an expanded data strategy, new processes and planning, and a tight alignment between quality and regulatory teams.
Join Rimsys for an interactive panel discussion about MDR/IVDR post-market requirements, how they’re influencing regulations in other markets, and best practices that companies can adopt to ensure compliance.
- The elements of effective post-market surveillance plans
- Reporting requirements for different product types and risk classes
- Strategies to increase collaboration between regulatory and quality teams
Director of Product, Post-Market,
Director of Quality,
Chief Business Developer, North America, Atostek
December 8, 2022 | 12 PM CT
In partnership with:
The intersecting threats of health inequities along with modifiable global risk factors for CVD (obesity, diabetes, hypertension, dyslipidemia) significantly increase health disparities and are critical factors in patient outcomes. Social determinants of health—ranging from insurance coverage, stress, access to healthy food and safe places for physical activity—can compound risks for CVD and related comorbidity and mortality. This solutions-oriented webinar roundtable will bring together cardiovascular care experts and medical innovators to discuss tested community approaches to addressing cardiovascular disease inequities as discussed in the hot topics podcasts. The webinar will also explore solutions for policymakers to consider.
Rachel M. Bond, MD,
System Director of Women’s Heart Health, Dignity Health
Chloe Villavaso, MN, APRN,
Clinical Faculty, Tulane University School of Medicine
Foluso A. Fakorede MD,
Cardiovascular Solutions of Central Mississippi
January 24, 2023 | 10 AM CT
Sponsored by IPM
- Minimizing compliance risks through enhanced organizational approaches (culture, processes, systems)
- Managing compliance issues to prevent business crises
- Managing crisis events when they occur
- Leading remediation programs
- Learning from non-compliance experiences to drive continuous improvement
Director of Operations,
ON-DEMAND DIGITAL EVENTS