RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 

Twin Cities Webcast: EU MDR Audit Prep and Case Studies

1.0
RAC Credits
Tuesday, 06 October 2020 (12:00 PM) - Tuesday, 06 October 2020 (1:00 PM) Central Time (US & Canada)

Member: FREE
Nonmember: $20


Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

R&Q is supporting many medical device companies with their transition from MDD to MDR. These companies span a wide range of clinical specialties, notified bodies, and geographic locations. R&Q's involvement in client notified body audits and remediation efforts and conducting internal and mock MDD/MDR audits for device companies, provide us with a significant amount of audit data and valuable notified body perspectives.

This session will present case studies of audit findings by functional area (risk management, post-market surveillance, etc.) and where to expect notified bodies to focus. Other topics covered address strategies for getting prepared for your audit, managing your audit, and responding to audit nonconformances. The session's overall objective is to arm participants with audit prep information so that they can focus on resources in the correct areas and achieve MDR certification.

The webcast will conclude with a Q&A segment.

This event is brought to you by the RAPS Twin Cities Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit. 

Learning Level:  Intermediate 

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

This webcast is available to RAPS members for free
. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections.
 


Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. Registration will close 48 hours prior to the event. 

Featured Speakers:
Nancy Morrison, executive director, Regulatory and Quality Consulting Services
Ron Sills, senior principal specialist (former lead auditor, medical, TUV Rheinland), Regulatory and Quality Solutions LLC (R&Q)

Register