Watch our webinar where we address major challenges in software qualification and classification for different functionalities. We explore MDR for software-hardware combinations and how AI is handled under the AI Act. In addition, we share essential resources, key standards, and guidance documents crucial for getting your product to market, from design and development to clinical evidence and technical documentation.
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Join us as our expert speakers share valuable insights and practical knowledge drawn from extensive industry experience.
Senior Consultant RA MD
With 3 years at the QbD Group as consultant in Regulatory Affairs for medical devices, Caroline’s main expertise lies in Medical Devise Software (MDSW). Before this, she spent 5 years at Materialise, focusing on MDSW and CM implants.
SaMD expert & Project manager
Pieter is a seasoned SaMD/MDSW expert with extensive experience in EU and US regulations and standards, especially in AI and cybersecurity regulatory requirements. His expertise covers compliance with regulations like MDR/IVDR and FDA legislation, alongside standards such as ISO 13485, IEC 62304, IEC 82304, ISO 62366, ISO 81001, and ISO 14971. In addition to his technical expertise, Pieter brings valuable project management experience in the pharmaceutical and medical device industries, helping organizations solve complex problems and implement effective solutions to achieve their goals. Pieter’s Mission: To prove that compliance and innovation can go hand in hand while staying at the forefront of the evolving landscape of SaMD/MDSW legislation and standards _._
Keep watching
点播网络研讨会Building on QbD Group's Landing in Europe MedTech whitepaper, this webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.
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点播网络研讨会Join our webinar to explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices. We’ll discuss the critical role of clinical validation starting from the design phase and guide you on how to compile the necessary evidence to meet MDR requirements.
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点播网络研讨会This webinar will explore the specific requirements for various safety classifications and provide valuable insights into what Notified Bodies (NBs) and the FDA expect from your development process. Key topics will include the full development cycle, cybersecurity essentials, usability engineering, AI integration, and effective strategies for aligning agile methodologies with the strict release flows required for MDSW. Gain a deeper understanding and streamline your MDSW development process today!
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