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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Among the key areas open to interpretation and which need further guidance in the IVD-R text are:
Maurizio Suppo, Owner & VP, Qarad will explore these topics in detail with clear "how to do" examples during a two-day, in-person workshop at the Hilton Rotterdam in The Netherlands on 18 and 19 October.
Delegates will acquire an in-depth understanding of how to create and organize the technical documentation related to IVD devices and common mistakes and pitfalls to avoid to ensure a right-first-time submission to their notified bodies.
The practical implications of clinical evidence and performance evaluation of IVD devices across all the spectrum of the four regulatory classes (A, B, C and D) will be covered. And specific attention will be given to the applicability of clinical evidence requirements to Class A devices and to the importance of a flawless design control process for the Annex IX conformity assessment procedure.
Before 18 September 2022: Member € 945 | Nonmember € 1,120
After 18 September 2022: Member € 1,080 | Nonmember € 1,264
Maurizio Suppo, Owner & VP, Qarad
With a PhD in molecular biology from the University of Turin (Italy) in 1985, Maurizio has more than 34 years of experience in the field of regulatory affairs and quality systems in the in-vitro diagnostic (IVD) industry. He held executive positions at Sorin Biomedica (now DiaSorin), Becton Dickinson, Dade Behring and Siemens Healthcare. He has been director of the European Diagnostic Manufacturers Association (EDMA) and, in that role, represented the IVD industry position in the drafting of the European IVD Directive 98/79/EC.
His knowledge and experience in RA&QS go beyond the European borders. A trained ISO-9001 & 13485:2016 auditor, Dr. Suppo is also an expert MDSAP auditor with more than 500 MDSAP audit hours as a lead auditor.
Maurizio Suppo joined Qarad in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences and published more than 20 articles in the specialized press. He is fluent in Italian, English, French with a good knowledge of Spanish.
Pieter Bogaert, Device Compliance Expert, Qarad
Pieter Bogaert is an IVD specialist with a wealth of experience in flow cytometry. Pieter graduated with a Ph.D. in Biotechnology at Ghent University, after which he stayed on to work there. He later expanded his knowledge by working as a Flow Cytometry specialist at BD Biosciences and Cerba Healthcare. Pieter has written multiple articles, published in various international, peer-reviewed journals. At Qarad, Pieter’s responsibility is to ensure compliance of IVD product technical documentation with the European Regulation. This includes gap assessment and other consulting services, as well as technical file writing and compilation. Given his previous professional experience, Pieter’s in-depth areas of expertise are medical laboratory devices, clinical flow cytometry reagents and instruments.
Day 1 – 18 October 2022
Registration and Welcome Coffee
General introduction to the IVD-R
- major differences between IVD-R and the old IVD-Directive
- clear understanding of the transition period
- Notified Bodies – who are they, how they work, how to work with them, who controls them
- clear definition of IVD, main device & components vs accessories
- IVD Legacy Devices - instruments & reagents
- General Safety and Performance Requirements
- Classification of devices
- Conformity Assessment Procedures
- What is Technical Documentation ? TD format.
- Performance Evaluation of IVD Devices
- Identification & Definition of State Of The Art
- Clinical Evidence
- Performance Evaluation Plan
- Scientific Validity
- Analytical Performance
- Clinical Performance
- Clinical Performance Studies, Plan & Report
- Performance Evaluation Report
- Design Control best practices
Close for the Day
Day 2 – 19 October 2022
Continuation day 1
- Placing IVD on the market vs making available vs putting into service. Understanding the regulatory terminology & how it relates to the commercial activities.
- IVD-R impact on legacy devices
- Post market surveillance
- Market Surveillance
- Understand relationship between PMS and PMPF
- Proactive use of PMPF Studies
- Understanding the definition, role & obligations of Economic Operators. Why they are essential in the PMS process. How to deal with them.
- Supplier Management as per IVD-R. Standard vs custom suppliers / contract manufacturers.
- Quality/Regulatory Agreements. Key points to address
- How to ensure compliance and a smooth cooperation between the various actors in the supply chain.
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 room 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.
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 email@example.com. 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.
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 firstname.lastname@example.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.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email email@example.com