About the Conference

Massive changes are afoot in global regulatory and quality requirements for the medical device industry, including the European medical device and in vitro diagnostics regulations, new clinical evidence requirements, updated standards, and mandatory participation in the MDSAP program for those wishing to distribute products in certain markets.

Manufacturers need not only to change current procedures but to evaluate and remediate legacy products that will remain on the market.  There are phase-in periods for the new requirements, but they are never as long as one might like, and there are always unanticipated complications and delays.

Strategic planning, assessment of products and procedures, and the design and implementation of new SOPs are complex, costly, time-consuming activities.  And there will be fewer and more overworked notified bodies to assist companies in the future.

In this highly interactive conference, the two largest and most experienced notified bodies, together with experts from companies well advanced in planning for the upcoming changes, present the issues and requirements, experience, and best practices for efficient compliance and remediation.

 

Who should attend:

Medical device and IVD professionals in:

  • Regulatory affairs
  • Quality assurance
  • Compliance / auditing
  • R&D
  • Clinical affairs
  • International affairs
  • Postmarket surveillance
  • Management

 

What you will learn :

  • The new EU Medical Device Regulation
  • The EU In Vitro Diagnostic Medical Devices Regulation
  • Timelines and implementation of the new regulations
  • Strategies for remediation of legacy products
  • Changes in EU Clinical Evaluations
  • The changing roles and number of notified bodies
  • New standards and other requirements
  • Strategies for efficient compliance with overlapping new standards and requirements
  • Provisions and implementation of the MDSAP program
  • UDI and the EUDAMED database
  • Staffing and organizational planning for the upcoming changes
  • Case studies

 

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • Where

  • Hogan Lovells
    Washington, DC 20006
    USA
    555 13th Street

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