Program Fees: (per workshop)

Opening date through 8 September
Member:             €850
List:                        €950  

From 9 September through 4 October
Member:             €950
List:                        €1050

*Netherlands charges 21% VAT

Location:

Park Plaza Victoria
Damrak 1-5, 1012 LG
Amsterdam, Netherlands
RAPS European Workshop on IVDR

RAPS European Workshop on IVDR
8-9 October 2019

The in-vitro diagnostics (IVD) sector faces a significant challenge to plan for and comply with new IVD regulation (IVDR) before May 2022. The transition from the current IVD Directive to meeting the new requirements involves significant preparation and data generation to be ready for additional notified body review and scrutiny. It is vital that IVD manufacturers get started early to fully understand the requirements and calibrate how to meet new expectations. This workshop connects you with IVD regulatory experts through hands-on interactive exercises where you will learn how regulatory professionals are planning and working towards achieving full compliance by 2022. This two-day workshop is an invaluable opportunity to share experience and gain confidence from discussions with experts and peers; it will be particularly valuable to all regulatory professionals responsible for achieving compliance for legacy CE IVDD products and new IVDs intended for the European market.

 
RAPS European Workshop on 510(k) Basics and Working with FDA

RAPS European Workshop on 510(k) Basics and Working with FDA
10-11 October 2019

Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the Federal Food, Drug, and Cosmetic Act. To market some types of Class I and most Class II devices in the US, you need to submit a 510(k) submission to FDA and receive FDA clearance. While the underlying data used to support the 510(k) submission may be similar to requirements in other jurisdictions, the regulatory requirements and submission process are very different. The purpose of this workshop is to provide participants with an understanding of the regulatory fundamentals; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and how to engage with FDA.

 
RAPS European Workshop on Software as a Medical Device

RAPS European Workshop on Software as a Medical Device - SOLD OUT!
10 October 2019

This workshop will review the current and evolving regulatory requirements both in the EU and US for software as a medical device (SaMD). Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Issues to be addressed include how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under US and EU requirements. Performing risk management/assessments for software is generally more challenging, so the session will include practical case studies to work through completing the required evaluations. This workshop will be particularly beneficial to regulatory professionals, QA professionals and application developers who are responsible for managing and planning regulatory compliance for software products.

 
RAPS European Workshop on MDR

RAPS European Workshop on MDR
8-9 October 2019 -SOLD OUT

The new medical device regulations (MDR) take effect in May 2020. This two-day workshop brings together thought leaders on MDR for discussion and hands-on exercises to review progress, share concerns and help make sense of the new expectations. This is not an entry-level workshop; it is a unique opportunity to review the requirements, understand the practical solutions and calibrate how much data is needed to achieve compliance. Share experiences gained in working through transition issues and confirm confidence through discussions and practical exercises with experts, peers and colleagues. This workshop will be particularly valuable to all regulatory professionals responsible for achieving compliance for both legacy CE MDD and innovative new medical devices intended for the European market.