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Complimentary ON-DEMAND Webinar

Recorded on August 30, 2022 

Getting Your Regulatory Ducks in a Row - Why a Regulatory Information Strategy is Critical for Successful MDR/IVDR Transitions

Learning Objectives:

  • Understand the information (submission and maintenance) requirements for key facets of MDR and IVDR, and how they compare to MDD/IVDD.
  • Evaluate current information management approaches, and their ability to support long-term compliance.
  • Employ digital strategies to improve information management, increase efficiency, and ensure medical device and IVD products remain compliant and on the market.

Digital strategy and regulatory changes aren’t always considered in tandem, but the significant changes introduced with the MDR and IVDR regulations have created both a need and an opportunity for RA teams to leverage a better approach to regulatory information management. This webinar explores the new information requirements associated with MDR/IVDR including GSPRs, UDI/EUDAMED, and Post-market surveillance and reporting.

Successful compliance with all of these information requirements will be hard to achieve for teams that aren’t also thinking through how they digitize and manage information internally. In the broadcast we’ll outline some of the challenges associated with traditional approaches to regulatory information management, and how a shift to a product-centric vs project-centric approach can make information more accessible and usable across teams and processes.

SPEAKERS

James_Gianoustsos

James Gianoutsos
CEO & Founder
Rimsys

James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James has extensive experience in establishing and maintaining quality management systems and has helped develop and submit multiple regulatory filings including. James holds a Bachelor of Science in operations management as well as an MBA from the University of Pittsburgh.

Bruce McKean

Bruce McKean
Director of Regulatory
Rimsys

Bruce McKean is the director of regulatory at Rimsys Regulatory Management Software. He has more than 25 years of medical device industry experience as a regulatory professional specializing in quality and regulatory (Q&R) compliance, design controls, and Q&R-related mergers and acquisitions. During his career, McKean has focused on implementing and maintaining design controls, product submissions, quality management systems internal to his company and for newly acquired companies, corporate Q&R internal audit programs, and performing Q&R due diligence audits on target companies. Prior to joining Rimsys, he served as director of Q&R operations at Philips Healthcare.

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