Event Recap: RAPS Utah/BioUtah Seminar – “Transitioning to New EU MDR & EU IVDR – Post-Market Surveillance, Clinical and Usability Studies” hosted by MasterControl

April 12, 2019

Approximately 90 attendees joined us on March 28, 2019 for this event, “Transitioning to New EU MDR & EU IVDR – Post-Market Surveillance, Clinical and Usability Studies,” hosted by MasterControl.
Participants were first able to hear from the following speakers:
*    Robert Wolfarth, Chapter Chair of new RAPS Utah chapter; and Senior Manager, Regulatory Affairs, Merit Medical Systems, Inc.
*    Kelvyn Cullimore, President and CEO of BioUtah
*    Matt Lowe, EVP of Product, MasterControl
Following the opening remarks, three life sciences professionals spoke on a general overview of the situation; Post-Market Surveillance, Vigilance and Market Surveillance; Clinical Evaluation and Clinical Investigations; and the parallel chapters of the IVDR. The speakers were  Dr. Michael Rinck, PhD (managing director, pharmacist and microbiologist, Promedt Consulting GmbH), Linda Chatwin, RAC, JD (senior customer solutions consultant, Health Sciences Division, Emergo, a UL Company), and Dr. Kristen Kanack, PhD (senior vice president, regulatory and clinical affairs, BioFire Diagnostics, LLC).

The event concluded with a Q & A session between the audience and the three featured speakers.

If you missed the seminar, please still feel free to contribute to the online RAPS discussion group to continue questions: https://connect.raps.org/utah/home