Hi Anon,
The MDR is my prep material, focusing specifically on:
• Conformity of the Devices
• Technical Documentation
• Post-marketing Surveillance
• Vigilance
• Clinical Investigations
RAPS has provided an RCC Exam Study checklist but some areas of the checklist are vague (when compared to the IVDR study checklist). The notified body my company works with also has white papers which may be helpful. Other than that, I'm also hoping my experience with MDR submissions/approvals helps. Wishing you good luck!
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Christine Stahley RAC
Regulatory Affairs
Grafton MA
United States
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Original Message:
Sent: 14-Oct-2023 23:14
From: Anonymous Member
Subject: RCC exam prep
This message was posted by a user wishing to remain anonymous
Hello RA folks!
I plan on taking the RCC MDR exam in the spring of 2024. For those currently preparing for the same, could you please suggest some prep materials or useful sites I can refer to?
Thank you in advance :)