The medical device sector is one of the most complex and challenging business segments of the healthcare industry with close collaboration between science and engineering. The main objective of the regulatory harmonization is to improve the efficiency of national economies and their ability to adopt to change and remain competitive.

Due to the Medical Device Regulation and In Vitro Diagnostics Regulation both the device and diagnostic industries are preparing to achieve compliance while continuing to look out for further developments. As notified bodies play an enhanced role in the European healthcare setting under new rules, the industry is still anxious to learn more about challenges and collaborations. It is critical for the industry to understand the increased focus on new responsibilities and requirements for all operators involved in distribution under the upcoming rules. Although MDR and IVDR will be explored, further topics will be addressed to ensure a holistic approach to current European regulatory affairs challenges.

The conference will bring together leading professionals from the medical device industry, regulatory affairs sectors from across Europe to discuss the future strategies for medical device companies. The main topics will be focused on Compliance, Risk, Quality Management, Regulations in Emerging Markets and Europe, FDA expectations, etc. The conference also offers a specific networking opportunity – meeting senior representatives from the market. Leading regulatory experts in the medical device sector will provide you with tools and analytic techniques to make your business goals come true.



  • Explore the European Regulatory framework
  • Share strategies with fellow decision makers in the industry
  • Discuss main regulation challenges
  • Learn about the proposals of the European Commission
  • Find out how Medical Device companies are facing the challenges of the changing regulatory environment
  • Outline key issues such as Compliance, Risk Classification & Management, Quality Management, FDA expectations for pre-submission applications, MDSAP program, the 510(K) reform & guidelines for submissions.
  • Get the latest information on how to face the common challenges in the industry
  • Benchmark your internal communication and improve with the help of market peers
  • Meet and get connected with leading players from the Medical Device market


SVPs & Vps & Heads & Directors & Managers of Regulatory
Affairs, CEOs, International Regulatory Specialists, Software
and Regulatory Engineers, Compliance and Quality Specialists,
Safety Risk Managers, Senior Surveillance & Distribution
Quality Managers




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