Join Us for an Exclusive Cardiovascular Training Program

Drawing on expert speakers from industry and formerly with the FDA, this intermediate-level training program will guide attendees through the process of going from product idea through approval, and each of the critical stages in between. With a focus on cardiovascular device development and validation, the program will include regulatory strategy, critical elements such as IDE, 510(k), and PMA submissions, clinical trial design, protocol development, human subject protection regulations, and risk-based approaches to clinical trial oversight.

The speakers will get to the heart of the matter with guidance that isn’t available in any guidance document in order to help attendees better understand how to work with the FDA through this process. In addition, the first 10 attendees to register will be offered 30 minute one-on-one sessions with former FDA reviewers and industry experts to discuss specific questions or concerns following the course.

agenda button (1)Learning objectives:

  • Verbalize an understanding of the FDA medical device approval process
  • Identify strategies for FDA interaction
  • Identify the appropriate regulatory pathway for various product types
  • Discuss requirements for a clinical trial protocol and various protocol design considerations
  • Discuss strategy for risk-based oversight of different types of clinical trials

flyer buttonWho should attend?

  • R&D engineers
  • Regulatory affairs personnel
  • Clinical team members
  • Medical Writers
  • Project managers 

register buttonSpeakers include:

Semih Oktay, President and Founder of CardioMed Device Consultants
Jessica Boyle, Director of Clinical Trial Services at CardioMed Device Consultants
Sandra Maddock, CEO and President of IMARC Research

View the flyer for complete bios.

Hosted at IMARC: 22560 Lunn Road, Strongsville, OH 44149