Medical Alley Association Events – Medical Alley Association

Medical Alley Association



Sponsored by:

Rimsys logo

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.

We’ll discuss:

  • 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
Adam Price Headshot

Adam Price,
Director of Product, Post-Market,

Kelly Stanton,
Director of Quality,

Juhani Perhonen Headshot

Juhani Perhonen,
Chief Business Developer, North America, Atostek

In partnership with:

ABC logo
PCNA logo

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.

Dr. Rachel Bond Headshot

Rachel M. Bond, MD,
System Director of Women’s Heart Health, Dignity Health

Chloe Villavaso Headshot

Chloe Villavaso, MN, APRN,
Clinical Faculty, Tulane University School of Medicine

Dr. Fakorede Headshot

Foluso A. Fakorede MD,
Cardiovascular Solutions of Central Mississippi

Sponsored by IPM

IPM logo
Medical device and diagnostic organizations often face disruptive events requiring dedicated leadership to achieve successful outcomes. Warning letters, consent decrees, product recalls, regulatory inspections, and supply chain disruptions require immediate attention, and delays can be costly. In medical technology, these crises have the potential to upend operations, financial metrics, and reputations. Your response can be the difference between mitigation and disaster.

We will talk through best practices to handle disruptive events that may distract your organization from its day-to-day business. The conversation will provide real-world experiences, advice, and strategies to help guide you on the path to minimizing the impact of crises that are inevitable in these industries.

Join us as we explore how to prevent the disruptive events you can and quickly and effectively respond to the ones you can’t.

  • 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
Tim Ehr Headshot

Tim Ehr,
Director of Operations,

Andy Myslicki Headshot

Andy Myslicki,
Managing Director,


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