Ensuring Compliance for your IVD’s Performance Evaluation – Webinar

• What: Webinar – Ensuring Compliance for your IVD’s Performance Evaluation
• When: Tuesday, November 16^th at 10 am (EST)
• Where: Online Event
• How to Register: Ensuring Compliance For Your IVD’s Performance Evaluation
• Why: Join us to examine the essential components of a PER and how to prepare key technical documentation under the EU IVDR

The new in vitro diagnostics regulation of the European Union, the IVDR 2017/746, will soon be replacing the existing IVD Directive on May 26th, 2022. The regulation is set to bring in drastic changes to the way the IVD medical devices are regulated by strengthening the old requirements in a variety of facets.

The IVDR changes have greatly increased the requirements for Performance Evaluations, which are conducted in the premarket phase. Further, it also mandates that the performance of devices be continuously monitored throughout the life cycle of the device. This continuous data collection and analysis will become an integral part of the Performance Evaluation Report (PER).

Join this featured presentation from our RA/QA Subject Matter Expert, Joseph-Richardson Larbi, who will cover the essential components of a PER and how to best prepare your technical documentation. He will also go over how to demonstrate an acceptable benefit-risk ratio and comply to the IVDR’s GSPRs for both legacy and new IVD medical devices. This session will also discuss the requirements for drafting a PER and the common pitfalls to avoid based on Celegence’s current IVDR projects.

Celegence will be hosting the WEBINAR on Tuesday, November 16^th at 10 am EST. Register online now.

• Joseph has 20 years of experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).
• His key expertise includes the preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE marking, and notified body opinion submissions.
• Medical device industry – Joseph has experience in diabetes management devices, nicotine replacement therapy (NRT) devices and pressurized metered dose inhalers (pMDI).
• Joseph has worked for small, medium, and large Biotech companies such as Roche, OBG Pharmaceuticals, and Kind consumer Ltd.

• The requirements of the IVDR for drafting a PER
• How to apply the industry best practices for systematic literature reviews
• Discussion on how to navigate the common obstacles when drafting a PER to ensure a smooth notified body or competent authority submission

Upon conclusion of the program, you will be able to:

• Understand the performance data requirements under the EU IVDR
• Learn how the requirements could affect your current product lifecycle approach/QMS
• Hear Joseph’s practical tips and guidance for implementation
• Examine examples and relevant case studies
• Have your most pressing questions answered during the Q/A session

This webinar is aimed towards those working for companies in the life sciences industry, particularly manufacturers of IVD medical devices, with a special emphasis on:

• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Device Design Managers
• Clinical Managers

Ensuring Compliance for your IVD’s Performance Evaluation webinar will be held on Tuesday, November 16^th at 10 am EST. Make sure you secure your spot at the webinar by registering now.

Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant IVD device expertise to navigate the EU IVDR regulations and gain market approval. We leverage a global team of consultants to provide local regulatory insight, strategy, and intelligence. We are happy to share our insights with you during this webinar and hope that you can join us then.

Celegence’s comprehensive support for creating and maintaining required PMPF documentation can help ensure your organization’s IVDR compliance. Reach out to us at info@celegence.com to learn more, contact us online or read more about Celegence’s medical device services.