Access the On-Demand Recording

On 27 July, 2021, RQM+ hosted a webinar addressing the urgency of IVDR, the biggest challenges in achieving compliance, and strategies to overcome those challenges. Fill out the form to watch the on-demand video now.

What You Can Expect to Learn

How to:

  • Engage notified bodies and understand the review process so you can avoid having to start your application all over
  • Find hidden IVDs in your portfolio and determine the correct intended use of IVDs, which will impact classification
  • Work with economic operators to include their new obligations under IVDR
  • Ensure alignment between your QMS, technical documentation, economic operator processes, and critical supplier processes so you can be fully prepared to meet all NB requirements
  • Get technical documentation into compliance in order to ensure alignment between your PEP, PER, PMPF, PSUR, and SSP
  • Build your team’s knowledge of IVDR across all functions, not just regulatory, in order to break out of silos and level up
  • And much more!

Learning Level

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.

 

Meet the RQM+ Experts:

Our presenters have a combined 35 years of experience leading global regulatory teams, in new product development research and regulatory consulting, and in pre- and post-market regulatory roles

Kristen Meany, MS, CQA, RAC (U.S., EU)

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  • 20 years leading global regulatory teams
  • Knowledge of regulatory strategy and all type of submissions
  • Diverse product knowledge of medical devices and IVDs
  • Experience negotiating with regulatory bodies

 

Felicia Hosey, RAC

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  • 15 years in new product development research and regulatory consulting
  • Experience with global medical device regulations
  • Work with tool and template development for MDR and IVDR

 

Ashley (Ash) Clark, MS, RAC

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  • 8 years in pre- and post-market regulatory roles
  • Experience with MDR and IVR remediation support
  • Focus on the impact of Brexit on MDR and IVDR implementation
  • Expertise in providing strategic solutions for IVDR compliance

 

Amie Smirthwaite, BEng, Ph.D.

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  • 25+ years in postdoctoral experience in medical devices
  • Former Global Head of Clinical compliance for BSI Notified Body
  • Built clinical compliance team and lead clinical aspects of successful MDR designation
  • Member of ISO technical committees 194 (Biological and clinical evaluation of medical devices) and 150 (Implants for surgery), a contributor to ISO 14155 and new proposals for clinical evaluation standards

Fill out the form to register to access the on-demand webinar.