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RQM+_Live_60_Recorded

On Thursday, 22 Sept., RQM+ subject matter experts hosted episode #60 of our Live! show, “RAPS Convergence Takeaways: RQM+ event speakers share their biggest surprises and learnings.” Fill out the form to get access to the on-demand recording now.

Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We also answer your questions in the process!

This RQM+ Live! show discusses the biggest takeaways and surprises from this year's RAPS Convergence. We cover at least a little bit of the subject matter in each of our speaker's sessions, including:

  • Clinical evaluation
  • Recent developments in EU Regulations (MDR and IVDR)
  • Post-market clinical follow-up (PMCF) and risk management
  • Developing IVDR-compliant intended purpose statements that serve the business and meet notified body expectations 
  • How to efficiently prepare your eSTAR submission 

Whether you attended RAPS Convergence or not, we promise that this session will deliver value and answer your lingering questions. Please sign up to access the recording by filling out the form.

Meet the RQM+ PANELISTS:

kuttiJaishankar (Jai) Kutty, Ph.D.
VP, Intelligence & Innovation

Jaishankar "Jai" Kutty is Vice President of Intelligence & Innovation. He has a Ph.D. and joined RQM+ last year, coming from BSI, where he spent seven years in CE marking technical and clinical leadership roles, with specific expertise in cardiovascular product development.


Carlos headshot Carlos Galamba, MSc
VP, Intelligence & Innovation - IVD

Carlos joined RQM+ in September 2021 after seven years at BSI, where he was responsible for managing, coaching and developing a global team of IVD technical experts in his role as a Technical Team Manager. He was BSI's first internal clinician under the IVDR and had oversight of most performance evaluations in that role.


celeste_square-min Celeste Maksim, Ph.D., RAC
Chief of Staff

Celeste is Chief of Staff for Clinical & Post-Market Services. Celeste has extensive experience with clinical studies and post-market surveillance, and at RQM+, her focus is on developing strategies to meet the EU MDR requirements for clinical and post-market surveillance compliance documentation.

 


anike Anike Freeman, M.Eng., PMP
Principal Consultant

Anike is a Principal Consultant at RQM+. Anike has a long, award-winning history with CDRH, including a role as Senior Consumer Safety Officer, where she managed division operations for many years.

 


Nancy Morrison Square Nancy Morrison, RAC (moderator)
Vice President, Intelligence & Innovation

Nancy has more than 30 years of quality and regulatory experience in the medical industry with U.S. and global regulatory submission experience. She has spent the last nine years with RQM+, providing EU MDR and IVDR leadership in developing solutions and implementing the regulations at startup, mid-size and multinational medical device and combination product companies. 

Fill out the form to register for the Live! show.