Regulatory

Emerging technologies, new regulations and a variety of other factors all contribute to the ever-evolving medical technology regulatory landscape.

Below are just a few of the Regulatory sessions offered at The MedTech Conference 2018.

The MedTech Conference provides the ideal environment for regulatory affairs professionals to learn about and discuss navigating complex regulatory pathways. The 2019 conference program will be available late spring 2019.


CDRH Town Hall

Get an exclusive peek into FDA’s Center for Devices and Radiological Health (CDRH), and a rare opportunity to interact directly with Jeff Shuren and other senior office leaders from CDRH.

State of the Art Global Best Regulatory Practices for Medical Device Regulators

This panel explores WHO guidance for GRP and the WHO Model Regulatory Framework, with updates on how leading MD regulators are leveraging GRP with improved regulatory efficacy, including in the United States and Brazil.

Inspection Evolution: FDARA, Program Alignment and Beyond

Learn how FDA is operationalizing new inspection requirements in FDARA section 702, how Program Alignment is driving investigator expertise and a unified CDRH-ORA inspection strategy, how FDA is moving towards adoption of ISO 13485:2016 and the impact on device quality inspections and much more.

FDA and Industry Outside the Regulatory Box

This session highlights innovative FDA programs, how they might progress from pilots to permanent initiatives and how FDA will develop new approaches to support innovation and good quality practice.

Medical Technology Communications from Pipeline to Post-Market — New Policy Developments in Promotion, Scientific Exchange and Real World Value Based Innovation for Patients

Multiple critical perspectives on policies for communications about your technologies from thought leaders are considered, including patient, innovator and FDA.

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