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The unique challenges faced in earning approval for medical software products require a different approach from other medical devices. In addition, cybersecurity concerns and the rise of artificial intelligence bring new regulations and guidance documents published on a weekly basis.
Join Coenraad Davidsdochter of Qserve for a look at the history and current state of play of software as a medical device (SaMD). Global requirements will be discussed, including the EU and US regulations, along with:
Special attention will be paid to software lifecycle management and performing risk assessment. In addition, practical case studies will be presented for each subject.
Whether you are a regulatory professional, QA professional or an application developer responsible for managing and planning regulatory compliance for software products, join Coenraad Davidsdochter for this informative two-day workshop on SaMD at the Hilton Rotterdam, The Netherlands.
Before 17 January 2022: Member € 945 | Nonmember € 1,120
After 17 January 2022: Member € 1,080 | Nonmember € 1,265
Coenraad Davidsdochter, Software Expert, Qserve
Coenraad is a senior consultant, software and artificial intelligence with more than 20 years of experience in software development. He has more than 10 years of experience in setting-up, maintaining and improving Quality Management Systems (QMS) based on ISO 13485, MDD 93/42/EEC, MDR 2017/745 and GDPR 2016/679.
He has been responsible for deployment and management of QMS processes, Corrective and Preventive Action (CAPA), Change, Document & Record Control, Management Review, Technical file, Risk Management, Clinical Evaluations and Post Market Surveillance.
Weena 10, 3012 CM Rotterdam
RAPS has secured a discounted room block at the Hilton Rotterdam for workshop attendees. Please mention that you are participating in the RAPS workshops.
Check-in time is 15h00. Although the hotel will make every reasonable effort to accommodate guests who arrive before the check-in time, the client recognizes that guest rooms may not be immediately available. Baggage storage will be available. The hotel check-out time is 12.00 on the day of departure.Room Rate: € 165.00 per night
Book your discounted group rate here:
The Hilton Rotterdam is located in the city centre, just 500 metres away from Rotterdam Central Station.
There is a direct train connection from Schiphol airport to Rotterdam central Station which takes about 26 minutes.
For real-time information, please visit the mobile website OV9292.
Taxis are available directly from the airport outside the departure and arrival halls. You can choose a regular taxi, a luxury Schiphol Business Taxi or a Schiphol Travel Taxi minibus.
If you prefer to pre-order a taxi in advance, don’t hesitate to contact Schiphol Transfer Assistance (STA). Just call +31 20 601 3400 or visit the STA desk in Schiphol Plaza. You can find them in Arrivals 4, open anytime day or night.
The hotel has parking at a cost of € 30 per night.