Regulatory Affairs, Quality & Risk Management
Advance your expertise in EU certification and international regulatory strategies. Gain in-depth knowledge of MDR/IVDR, MDCG guidances, ISO 13485, ISO 14971 and other technical standards, as well as labelling requirements, UDI and EUDAMED.
e-Learning: Medical Devices Basics - A Quick Introduction
Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.Language: English
FDA MedTech Regulatory Update 2026
Get a compact update on key FDA requirements for medical devices in 2026 and practical guidance for your U.S. planning in 2027. The seminar covers regulatory pathways, FDA interaction, QMSR, clinical…Language: English
Clinical Strategy China (NMPA)
This seminar equips medical device professionals with a clear regulatory and operational roadmap for clinical evaluation and clinical investigations under China's NMPA framework. Building on existing…Language: English
Strategic Regulatory Affairs under the MDR
Regulatory strategy under the MDR calls for well-structured authority interactions, efficient internal processes, and the ability to identify and assess regulatory developments at an early stage. This…Language: English
Combination products: From CMC and quality data to a submission-ready regulatory dossier
The EU regulatory landscape for drug-device combination products is highly demanding. This seminar walks you through the regulatory landscape, from MDR, EU GMP, and ICH guidelines to marketing…Language: English
Contact
We are happy to provide you with personal and individual advice.
Our professional development portfolio is extensive. We would be pleased to discuss your requirements with you personally and help identify the most suitable options from our range of offerings. Let our professional development experts advise you and feel free to contact us today.
Verena Planitz
Conference Manager Healthcare
+49 6221 500-655
v.planitz@forum-institut.de