Software as a Medical Device

12.0
RAC Credits
Europe Europe In-Person In-Person
Thursday, 20 October 2022 (9:00 AM) - Friday, 21 October 2022 (5:00 PM) Central European Time (CET)
Weena 10
Rotterdam, Zuid-Holland, Netherlands, 3012 CM

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 18 September 2022: Member € 945 | Nonmember € 1,120

After 18 September 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.


Gert Bos, CSO-CEO, Qserve Group

Gert is an expert in European regulations based on more than 30 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic, regulatory and business consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer and consultant with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president of RAPS, and serves as board member of RAPS Europe, and founding board member of the RAPS NL chapter.


Agenda

Day 1 – 20 October 2022

 

9:00 (CET)

•      Introduction: Past, present, and future of medical device software:
Gert Bos, Qserve

•      SaMD - Definition, classification, and worldwide variations
Manufacturer

•      Recent developments; Artificial intelligence, Cybersecurity and privacy
Coenraad Davidsdochter, Qserve

•      Regulatory overview of medical device software in Europe; MDR, IVDR
Notified Body

•      USA FDA software regulation
FDA

17:00

Close for the Day

 

Day 2 – 21 October 2022

 

9:00 (CET)

•      The use of standards and guidance documents
Notified Body

•      Advantage of an early worldwide regulatory strategy for SaMD
Manufacturer

•      The perceived conflict of Modern software development techniques in a medical regulated domain Coenraad Davidsdochter, Qserve

•      SaMD and short development cycles, a COVID19 case study
Manufacturer

•      Forum discussion: all speakers, moderated by Gert Bos, Qserve

17:00

Close for the Day

 


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.


Event Policies

Vaccination Requirement

RAPS will require proof of COVID-19 vaccination for all participants attending RAPS in-person workshops & programs. Your well-being is RAPS’ #1 priority.

Unvaccinated individuals or those unable to provide proof of vaccination in advance will not be permitted to attend.

RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.

Cancellations and Refunds

All cancellation requests must be submitted in writing to support@raps.org. Cancellation requests received by Friday, 27 May 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 27 May 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org


Discover more of what matters to you

News »

  14;31;