The first critical step to CE marking may be harder that you think. Join us as we discuss best practices for delivering accurate and compliant applications that will be reviewed efficiently... and accepted by the notified bodies.

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RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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A "notified body application" for IVDR CE certification can feel like 510(k) submission to IVD manufacturers who are new to the notified body relationship. Notified bodies are quoting a range of < 1month to 6+ months review time based upon application quality. Per the notified bodies, the majority of applications have problems, so a 6+ month review time is currently the norm.

Errors and deficiencies are commonly found in the intended purpose, classification, code assignments, acceptability of product groupings, and verification and description of activities of suppliers, subcontractors, and manufacturing sites.

In this Live! show featuring former notified body representatives fresh out of their IVDR leadership roles, we'll discuss best practices for delivering accurate and compliant applications that will be reviewed efficiently, and accepted by the notified bodies.

  • Heike Möhlig-Zuttermeister​, Ph.D. Vice President of IVD Intelligence & Innovation
  • Carlos Galamba, MSc Vice President of IVD Intelligence & Innovation
  • Nancy Morrison, RAC  Executive Director, Regulatory & Quality Consulting Services
  • Felicia Hosey, RAC – Principal Advisor

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer