2021-June-16: Medical Device Summit, Breakout 1

Type: Recorded Event
Price: $15.00


Michigan Medical Device Summit - Breakout 1

Emerging Trends in Medical Devices: U.S. Regulation, Quality/Compliance and Risk Management 


Session Description

The disruptive impact of Covid-19 on the medical device sector has placed many regulatory and compliance teams under pressure. In addition to significant regulatory change prior to the pandemic medtech companies are now having to address fresh challenges and priorities. New FDA standards and guidances, potential overhaul of QSR, disruptions in inspections and approvals, are just a few influences on existing practices and processes. Hear experts talk about the latest in U.S. trends and emerging issues that are placing more emphasis on quality and risk management. 




Robin Rowe - President and Founder, R2 Medtech Regulatory, Clinical & Quality, LLC 



Nicole Baldridge - President and CEO, Baldridge Consulting, LLC 

Nicholas Werner - Senior Principal Consultant, Regulatory Affairs, Suttons Creek, Inc. 

Madison Wheeler - Director of Technical Operations, E.M.M.A. International 


Summit Description

Advancing Healthcare and Improving Lives Through Medical Technology 

The Michigan Medical Device Summit is a gathering of thought leaders, innovators, providers, and change-makers to discuss critical issues facing the state’s medical technology sector. The medical device industry was upended as the Covid pandemic raged, resulting in expansions, pivots, and recalibration – but business went on, it had to for most. The Summit will provide strategic insights on the latest in medical device innovation and manufacturing, regulation and compliance, supply chains, market access, and more. OEMs, contract suppliers and providers, academics and other professionals involved in Michigan’s medtech sector can garner new knowledge, tactics and best practices, while making valuable connections in this interactive event. 

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