No matter our role within MedTech, we all have a responsibility to protect patients. Furthermore, we want our companies to maintain a positive reputation in the market. For these reasons, the best time to exercise your responsibility as a quality and regulatory leader is before the crisis hits. One of the most stressful moments in a working career can be telling a CEO they are about to enter a $40 million recall situation. Avoiding them entirely is best, of course – and this session will cover many of the best ways to do that – but handling them well if they do occur can result in significant savings.  

The facts are clear:

  • FDA has increased the number of recalls classified as Class I (most serious), with six so far just four weeks into the new year, setting the pace for another potential record year
  • The EU MDR requires that companies have a Person Responsible for Regulatory Compliance (PRRC), which places specific responsibilities on this leader
  • The costs in dollars, company reputation, and ongoing oversight by regulatory authorities (e.g., consent decree), is in the millions, or even hundreds of millions 

In this presentation and panel discussion, we will cover some of the best strategies for preparing for crisis management. More specifically:

  • Taking change control seriously, ensuring proper validation is performed, risk management is updated, and regulatory filings are amended
  • Aggressively evaluating the input and collecting of PMS data, as well as the importance of reacting to it early and consistently
  • Having clear decision points when potentially disastrous patient and business outcomes are possible, with an escalation path that gets organizational attention
  • Regular internal audits and responding to them (and how to give yourself the best chance to catch everything)
  • Preventing future action (withdraw of certification/warning letter/consent decree) by actively making significant quality improvements to company culture and processes 


  • Steven Niedelman - Lead Quality System and Compliance Consultant, King and Spalding
  • Scott Edwards - Managing Director, RQM+ 
  • Richard Freeman - Director, Global Audit Practice, RQM+ 
  • Steve Keverline - Managing Director, RQM+
  • Theresa Miles - Vice President of Business Development, RQM+ (moderator)