Major Regulatory Compliance Challenges for the Non-European Industry
29 Min
1 Lesson
Price
$75 Per person
Lecturer
Mindy Mc Caan
VP Regulatory Compliance, Qserve Group, USA
Mindy has multi-faceted medical device regulatory experience, having worked for a start-up, large global company and two notified bodies before joining Qserve, a medical device consulting company Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and executive has led to a practical approach in developing and implementing regulatory, quality and clinical strategies and supporting documentation.
Description
The new European regulations have presented the medical device industry with new challenges in order to ensure compliance to the MDR/IVDR and continue placing medical devices on the EU market. This session will identify some unique key challenges experienced by non-European medical device manufacturers in preparing for compliance to the MDR/IVDR, and the lessons learned and/or strategies being used by medical device manufacturers to address these challenges.
Related Courses
First Course
Nebojsa Serafimovic
16-17.06.23
1 Session
$100 Per person
Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
29 Min
1 Lesson
$80 Per person
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
34 Min
1 Lesson
$80 Per person
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
22 Min
1 Lesson
$70 Per person
