For Startups in the medical technology sector, understanding ahead the regulatory requirements is crucial while moving the firsts steps to place a medical device on the EU market. Success in this field is built on a foundation of innovation and rigorous adherence to quality standards, where factors such as usability, clinical and biological evaluation, and the strategic implementation of Software as a Medical Device (SaMD) enhanced by Artificial Intelligence (AI) play a critical role. Beyond complying with the stringent MDR requirements, much more needs to be considered to place a safe and compliant medical device on the market.
Join us for an exclusive Startups tailored event. The agenda features insightful keynote speeches, interactive workshops, and networking sessions to enhance your understanding of the Notified Body conformity assessment process. Experts will delve into how optimizing usability can enhance user safety and device performance, how comprehensive clinical and biological evaluations underpin product reliability, and how cutting-edge SaMD and AI innovations are reshaping regulatory framework.
This is your opportunity to gain key insights, connect with industry pioneers, and equip your venture with the necessary expertise to bring groundbreaking medical technologies to market.
Secure your spot now and shape regulatory challenges into opportunities.
AGENDA
09:30 – 10:00
Welcome coffee and Networking
10:00 – 10:10
Welcome and introduction of participating parties by Medical Valley EMN e. V.
Marco Wendel | Medical Valley
10:10 – 10:30
Introduction of BSI
Axinja Wolf | BSI
Certification processes and timelines | BSI’s services for startup
10:30 – 11:05
Medical Devices – MDR might not be enough
Stefan Bolleininger | Be on Quality
WEEE 2012/19/EU: Waste of Electrical and Electronic Equipmen • RoHS 2011/65/EU : Restriction of Hazardous Substances (EEE). • REACH: to improve the protection of human health and the environment from the risks that can be posed by chemicals. • European Battery Directive 2006/66/EG (BattG) • Compliance to RED (Radio Equipment Directive) Richtlinie 2014/53/EU for wireless communication technologies (WLAN), Bluetooth, RFID. • BSI-*TR-0316 Datensicherheit
11:05 – 11:20
Coffe break
11:20 – 12:50
Workshop: SaMD, AI & NB AI
Thomas Doerge | BSI
12:50 – 13:50
LUNCH
13:50 – 15:20
Workshop: Clinical & Biological Evaluation
Breda Kearney | BSI
Elisa Figallo | BSI
The importance of clinical evaluation and getting it right | Navigating the Risk-Based Approach for Medical Device Biocompatibility
15:20 – 15:35
Coffe break
15:35 – 16:20
Useful usability – What you need to implement and what can be argumented
Stefan Bolleininger | Be on Quality
What is the lowest level and at what point do products become better as a result?
16:20 – 16:30
Closing
