Certification is not the end, but the beginning of the journey for Medical Device Software (MDSW) (also known as Software as Medical Device (SaMD)). New functionalities, AI model updates, cybersecurity patches and changing user needs mean that software must continue to evolve. If manufacturers are not able to adapt to the demand of change, business growth might suffer as a result.
MDSW/ SaMD Changes may have implications for technical documentation, quality management systems and regulatory communication. In particular when it comes to communication and interactions with the Notified Bodies, approaches vary. Manufacturers therefore need clear internal responsibilities for assessing and managing software changes throughout the product’s lifecycle, while making sure the processes of their Notified Body match their business needs.
In this webinar, TÜV SÜD speakers will provide information about regulatory considerations associated with changes to certified Medical Device Software/ Software as Medical Device and dive into the process landscape of these changes at TÜV SÜD.
The session will cover:
The webinar will include an introduction of the categories of changes with examples, an expert discussion and plenty of time for live Q&A on this topic and your questions.
Marco Caproni – Global Director Software, TÜV SÜD Medical Health Services
Marco Caproni is Senior Product Specialist for Software & AI at TÜV SÜD and leads the Global Software Product Review Team. A recognized expert in medical device software, AI and cybersecurity, he helps manufacturers navigate software changes, regulatory expectations and Notified Body interactions throughout the product lifecycle.
Malte Knowles Schmidt – Global Portfolio Manager, TÜV SÜD Medical Health Services
As experienced Product Leader in MDSW/ SaMD devices, Malte knows what influences the value stream of these devices and how lean processes are indispensable enablers to drive growth. In this webinar he will share how manufacturers needs for agility match NBs capabilities to enable change.
This webinar is relevant for:
This webinar is in a three-part series focused on helping MedTech organisations understand how regulatory decisions can be used as a business asset, not a blocker throughout their development journey.
This webinar forms part of TÜV SÜD's broader Start-up & Investors Initiative, designed to help MedTech startups and investors understand how to make key regulatory decisions that impact business risks and commercialisation.
