Navigating MDR Comprehensive Insights & Practical Applications in the Medical Device Sector
Online Masterclass
- December 3rd - 4th 2024
- 9.00am – 1.30pm CEST (UTC+2)
Trainer
Dr. Felix Tobias Kern
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Introduction
Are you ready to navigate the complex landscape of the Medical Device Regulation (MDR) with confidence and expertise? Join us for an immersive webinar experience
designed for professionals in the medical device industry seeking to gain comprehensive insights and practical applications in MDR compliance. In this dynamic two-day webinar, participants will explore the fundamental concepts of the medical device sector and delve deep into the intricacies of the MDR. Through engaging presentations, interactive case studies, and hands-on workshops, attendees will:
- Gain a thorough understanding of the development and evolution of the medical device market, identifying opportunities and challenges for stakeholders.
- Explore the core components of the Medical Device Regulation (MDR), including its structure, requirements, and implications for industry players.
- Master the certication process for medical devices under the MDR, navigating the risk classication system and conformity assessment procedures with condence.
- Examine borderline classication cases, unraveling the complexities of distinguishing between medical devices and medicinal products and determining appropriate risk classications.
- Delve into the regulatory landscape surrounding clinical trials for medical devices, understanding the requirements for clinical evaluations, trials, and regulatory submissions.
- Establish robust market surveillance systems and liability management practices following MDR guidelines, ensuring product safety and compliance with reporting requirements.
- Participate in a dynamic workshop featuring practical examples and comparisons to FDA regulations, enriching your understanding of global compliance standards.
Whether you’re a regulatory affairs specialist, quality manager, clinical researcher, or legal advisor, this webinar offers invaluable insights and practical strategies to navigate the challenges of MDR compliance and thrive in the evolving medical device sector.
Target Audience
This advanced GMP Auditing course is tailored for professionals working in the pharmaceutical and biotechnology industries who are responsible for ensuring
compliance with Good Manufacturing Practice (GMP) standards. The target audience includes:
- Medical device manufacturers and providers - Professionals involved in the design, development, manufacturing, and distribution of medical devices, including engineers, product managers, and regulatory aairs personnel.
- Regulatory aairs specialists in the medical device sector - Individuals responsible for ensuring compliance with regulatory requirements, submitting product registrations, and maintaining regulatory documentation.
- Quality and compliance managers in the medical device industry - Professionals overseeing quality management systems, compliance with standards such as ISO 13485, and implementing best practices to ensure product safety and ecacy.
- Clinical researchers and medical professionals involved in conducting clinical trials with medical devices - Investigators, research coordinators, and clinicians engaged in planning, conducting, and reporting clinical trials to evaluate the safety and eectiveness of medical devices.
- Legal advisors and experts interested in medical device regulation - Lawyers, consultants, and regulatory experts providing legal counsel and guidance on navigating complex regulatory frameworks, interpreting regulations, and ensuring compliance with legal requirements.
- Other professionals and enthusiasts seeking to expand their knowledge of the medical device industry and MDR requirements - This may include students, academics, entrepreneurs, and professionals from related elds such as healthcare administration, biotechnology, and pharmaceuticals, who are interested in learning about the regulatory landscape and opportunities within the medical device sector.
Meet The Trainer
Dr. Felix Tobias Kern is Associate Director at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich. He is expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
In the past 10 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality, risk management, as well as regulatory requirements in the fields of medicinal products and medical
