> Jointly and Severally – How to Communicate Effectively with EU Notified Bodies
> MDCG 2019-6 Rev. 5 – Q&A on the requirements relating to NBs
> MDCG 2023-3 Rev. 2 – Q&A on vigilance terms and concepts as outlined in Regulations (EU) 2017/745 and (EU) 2017/746, January 2025
> The key to a successful submission – how to build an effective MDR/IVDR Technical File
> Digitization of regulatory submissions in the US – FDA eStar
> Artificial Intelligence (AI) as a tool to support Medical Device Regulatory Affairs
> Mercosur – The financial gateway to South America
> Anticipated Regulatory Changes in the MedTech Sector Across South America
> The twilight zone – EU MDR annex XVI devices with non-medical intended purpose
> Environmental & Sustainability regulations in Medical Devices – Compliance with RoHS, REACH, and WEEE
> China’s NMPA regulatory landscape – Registration, UDI, and clinical trials
> UK & MHRA Regulations Post-Brexit – Navigating UKCA marking requirements
> Real-world evidence (RWE) and Big Data in MedTech Regulatory Decision-Making
> Regulatory Strategies for Startups & SMEs – Cost-effective compliance and market entry approaches
> International Standards & Risk Management – ISO 13485, ISO 14971, IEC 62304, and more
> Regulatory strategy for Artificial Intelligence (AI) and Software as a Medical Device (SaMD)
> Unique Device Identification (UDI) and traceability – Global implementation strategies (EU, US, China)
> Point-of-Care, personalized medicine and 3D-printed devices – Regulatory pathways for innovative technologies
> Regulatory considerations for wearable Medical Devices and digital health – FDA, MDR, and global standards
> The future of Medical Device regulation and innovation – The role of AI, blockchain, and digital transformation
> India’s Medical Device Rules, 2017 – Transitioning from the Drugs and Cosmetics Act of 1940
> Regulatory landscape of Medical Devices in the Eurasian Economic Union (EAEU)
> Navigating the Medical Device Single Audit Program (MDSAP): Strategies for global compliance
> The endless pursuit – Regulation chasing technological advancement
> The Role of Regulatory Affairs in the Due Diligence Process.
> The critical role of the U.S. Agent and the Initial Importer for MedTech manufacturers OUS