May 26, 2022 is the IVDR date of applicability, which replaces the IVD Directive. The deadline sounds far away, right? Eh… not so, considering the significant changes your organization will need to make in terms of infrastructure, planning, and resources to proceed with successful implementation. Under the IVD directives, most manufacturers were able to self-certify to place their products on the market. This is changing with IVDR as now there is an expected increase in requirement for notified body certification changing from 20% to more than 80% of all IVD products. This poses significant challenges for organizations that self-certified in the past and we are here to help.
This webinar will help you assess your products from both the portfolio-level and technical documentation level.
From a portfolio perspective, we’ll cover:
– IVDR timelines
– Updated classification rules
– Requirements of clinical data
– Cost assessment for remediation activities
– ROI based on current and changing market share using a case-study portfolio as an example.
At the technical documentation level, we’ll address:
– Details of the updated classification rules
– Conformity assessment procedures
– Economic operators
– The impact of Brexit
– Required involvement from notified bodies (a first for many companies in this space)
– Requirements for performance evaluation reports
– Submission updates
– Strategies you can take to fit all of this together
Attendees should expect to leave this webinar with a clear understanding of the regulation and actionable takeaways to get their organization moving towards compliance. This webinar is especially perfect for you and will serve as your IVDR guide! Like any significant regulation change, planning is imperative to success and we walk you through key points to help you do just that!
Nancy Morrison – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)
Nancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.
Jon Gimbel, Ph.D. – Executive Director and CER Business Unit Lead
Regulatory & Quality Solutions (R&Q)
Jon has worked in the biomedical and medical device area for nearly 20 years, acting as a key member in a medical device startup, a consultant to a wide variety of medical device companies, and as a researcher on both academic and industrial projects. Having a thorough understanding of the ever-changing global regulations, Jon leads R&Q’s CER business unit and has been successful implementing regulations at multinational medical device companies: delivering business-balanced solutions for their business-balanced demands. Jon oversees clinical evaluations completed by R&Q and helps ensure compliance to MEDDEV 2.7/1 Rev 4. Jon also works with companies to develop strategies and plans to meet the new EU MDR requirements pertaining to clinical evaluations and post-market activities. Jon holds a Ph.D. in Mechanical Engineering and BioEngineering, and a Master’s degree in Mechanical Engineering, from the University of Pennsylvania. Jon received his Bachelor’s degree in the same subject from Penn State University.
Ron Sills – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q) (former TUV Rheinland)
Ron recently joined R&Q after collaborating with us on panel discussions, roadshow events, and webinars while a Lead Auditor of TUV Rheinland. He has authorizations for ISO 13485, ISO 9001, MDD, IVDD, CMDCAS and MDSAP. He's also a subject matter expert on sterilization technologies and validation, hygiene and clean room certification, and biocompatibility. In the past Ron has developed clinical evaluation report services, as well as providing expert research services for clients in the medical devices, pharmaceutical, and life sciences industries. He has also worked for medical device companies, including ACMI and US Surgical (Medtronic) as a QA Manager and QMS Management Representative.