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
- 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!
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)
- 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
- 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
- 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.
- 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