Live with FDA: Accelerating a Quality Culture at Your Medical Device Company

FREE ON-DEMAND WEBINAR
August 1, 2024

Live with FDA: Accelerating a Quality Culture at Your Medical Device Company

In an industry where patient safety and regulatory compliance are paramount, fostering a culture of quality is not just beneficial—it's essential.

FDA recognizes this, as evidenced by their participation in the Voluntary Improvement Program (VIP), which rewards device makers for their commitment to continuous improvement by lessening regulatory burdens. This program combines a globally accepted maturity model with FDA regulatory opportunities to accelerate device quality and manufacturing improvements.

Join us for an exclusive webinar to hear directly from FDA and ISACA experts about how you can become one of the top-performing device makers by leveraging the VIP. Learn how this program can help you enhance your quality standards, improve manufacturing processes, and achieve optimal business outcomes.

By attending this insightful session, you will:

Understand the VIP framework: Learn the foundation and best practices of this program, designed to streamline quality improvements and regulatory compliance.
Enhance FDA relations: Discover how VIP participants foster collaborative communication with FDA, building trust and transparency that reduces regulatory burdens.
Real-world success stories: Hear case studies of device companies that have achieved faster time to market, increased production capacity, and significant regulatory relief through the VIP.
Continuous improvement mindset: See the ROI from shifting your organizational focus from compliance-only to continuous improvement, unlocking long-term benefits for both your team and your devices.

Don't miss this opportunity to transform your quality culture and drive significant improvements in your medical device company's performance. Register now to secure your spot and take the first step towards achieving continuous improvement and excellence in device manufacturing.

Watch the webinar

Live with FDA Accelerating a Quality Culture at Your Medical Device Company (2)

Who should attend?

Quality Professionals and Management
Regulatory Affairs Professionals and Management
Medical Device Executives

Presented by

Moderator:
Etienne Nichols

Head of Industry Education & Insights,
Greenlight Guru

Presenter:
Erin Keith

Senior Advisor, Compliance and Quality Program, Office of Product Evaluation and Quality,
CDRH, FDA

Presenter:
Kim Kaplan

Senior Product Manager,
ISACA

In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress.

Visit their website to learn more.

The Voluntary Improvement Program (VIP) helps device makers design, build and deliver safer products to patients, faster. Developed in collaboration with ISACA, MDIC, FDA and the medical device industry as part of FDA’s case for quality initiative, this program identifies process inefficiencies and helps device makers implement best practices that accelerate medical device improvements. Participant outcomes include increased speed to market, improved production capacity, reduced regulatory burden & more.

Visit their website to learn more.

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.

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