Daniëlle Sleegers, MedEnvoy’s Director of Regulatory Affairs & PRRC, will be moderating the sessions, guiding you through the complexities of MDR/IVDR compliance. She will be joined by Salman Raza, a Notified Body expert, who will offer additional perspectives on the implementation and oversight of these areas.
Sessions in the series include:
MDR QMS Notified Body Assessment
March 19, 2025 | 10 AM CST – 11 AM CST
In this comprehensive session, we will guide you through the critical aspects of MDR compliance, covering both Quality Management Systems (QMS). We will discuss the relationship between MDR and ISO 13485:2016, including references to ISO, EN, Harmonized Standards and Annex Z, which shows how ISO 13485 coverage is integrated into the MDR. We will also delve into the QMS documentation and procedure requirements specific to the MDR, including common gaps observed during audits. This session will provide key insights into how to ensure your QMS is fully aligned with the MDR requirements.
This webinar has now expired:
MDR and IVDR Post Market Surveillance
March 26, 2025 | 10 AM CST – 11 AM CST
In this session, we will explore the critical elements of Post Market Surveillance (PMS) under the MDR and IVDR, including data collection, reporting adverse events, and how PMS feeds into continuous product monitoring. The session will cover how manufacturers can implement an effective PMS system to meet regulatory requirements and maintain patient safety. Daniëlle will also provide insight into how PMS ties into the broader regulatory framework. The session will end with a Q&A, so be prepared with any questions related to post-market activities.
Economic Operators Under the MDR and IVDR
April 2, 2025 | 10 AM CST – 11 AM CST
This session we will explain the roles and responsibilities of economic operators under the MDR and IVDR, including importers, distributors, and authorized representatives. We will walk through how each of these parties interacts with the regulatory framework and the compliance obligations they must meet. Daniëlle will also provide real-world examples of how economic operators play a key role in the lifecycle of medical devices and in-vitro diagnostics.
Comprehensive Overview of MDR Technical Documentation Requirements
April 3, 2025 | 10 AM CST – 11 AM CST
In this session, we will provide an overview of the Technical Documentation (TD) requirements under the MDR, focusing on the critical documentation needed for regulatory compliance. We will walk through the essential components of MDR compliant Technical Documentation, including the device description, intended purpose, risk analysis, clinical evaluation, and post-market surveillance plans.
We will also address the importance of ensuring that your technical documentation aligns with both MDR and ISO 13485:2016 standards. This session will include practical advice on how to organize and review your TD remotely, ensuring that it is complete, accurate, and in line with the expectations of notified bodies.
Speaker:
Daniëlle Sleegers
Director of Regulatory Affairs & PRRC, MedEnvoy Global
Biography:
Daniëlle has more than 15 years of experience in the medical device industry and has been hands-on in international registrations, post-market surveillance, clinical evaluations, and risk management. With her background in Biopharmaceutical Sciences and experience gained when working for the Medicines Evaluation Board of the Netherlands for 5 years before transferring to the medical device industry, she enjoys working in the medical device field to ensure regulatory compliance while supporting market access.
Speaker:
Salman Raza (MEng, MBA, MS)
Founder/CEO at Razalution Bureau
Biography:
Salman has worked in R&D, Manufacturing, and QA/RA consulting within the medical devices industry and subsequently worked over a decade as Lead Auditor/Technical Reviewer for reputable European Notified Bodies, including LRQA, SGS, NSAI, and GMED.
Salman’s expertise include:
-
- Member of ISO 13485:2016 standard development technical committee TC 210
- Recognized Lead/Principal Auditor by International Register of Certificated Auditors [IRCA]
- Certified Regulatory Affairs Professional [RAC].
- MDSAP certified Lead Auditor
- Technical Documentation Reviewer [MDR 2017/745]
- Author of forthcoming book ‘Life’s Non-conformities – An Auditor’s Tale’
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