Balancing Act Between Regulatory Requirements

Meeting the reporting requirements of regulations such as the EU Medical Device Regulation (MDR), and the legal requirements of the recently-mandated EU General Data Protection Regulation (GDPR), can be a daunting task. With seemingly clashing requirements, the balancing act that needs to occur within an organization to achieve compliance to both is a delicate one. Has your organization considered the impact of consistently meeting these two regulations simultaneously?

In this presentation from the 2018 Product Complaints Congress for Life Sciences, Kari Miller, Regulatory and Product Management Leader at Pilgrim Quality Solutions, examines both regulations and provides insight on the critical consideration for implementing them within your organization.

Discussion areas include:

  • An overview of the EU MDR and EU GDPR regulations
  • A look at the organizational impact of both regulations
  • The implementation process and system(s) considerations
  • Next steps in the achievement of compliance to MDR and GDPR requirements

Watch this video to learn more. »