Software as a Medical Device

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Tuesday, 15 February 2021 - Wednesday, 16 February 2021 (9:00 AM - 5:00 PM) Central European Time

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:

  • How to determine when software is considered regulated as SaMD.
  • How to determine correct class/classifications under global requirements.

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.

Pricing Amounts and Deadlines

Before 17 January 2022: Member € 945 | Nonmember € 1,120

After 17 January 2022: Member € 1,080 | Nonmember € 1,265

Speaker(s)

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.

 

Location

Hilton Rotterdam

Weena 10, 3012 CM Rotterdam

The Netherlands

Accomodations

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

Room includes:

  • Complimentary breakfast
  • Free WIFI Internet for all in-house guests
  • Tax (VAT)

Book your discounted group rate here:

Access & Public Transport

The Hilton Rotterdam is located in the city centre, just 500 metres away from Rotterdam Central Station.

Airport

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.

Taxi

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.

Parking

The hotel has parking at a cost of € 30 per night.