European Events

European Workshops

Developed by European regulatory professionals operating in Europe’s quickly changing and uncertain regulatory environment, RAPS' Munich workshops will bring together leading experts in the medical device, IVD, and cybersecurity industries.

Join us for one or more of the workshops below to gain insights into some of the most crucial issues facing regulators, manufacturers and regulatory professionals working with healthcare products for the European market.

FDA Pre-Submissions: The Most Valuable Tool in Your US Regulatory Toolbox

21 February 2023 - 22 February 2023

This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.

Technical Equivalence

21 February 2023 - 22 February 2023

This 2-day workshop will explore the topic of the pathway to establish technical, biological and clinical equivalence for EU conformity versus substantial equivalence pathways for the FDA. Learning objectives are described for each section.

Cybersecurity

23 February 2023 - 24 February 2023

€ 1155 Member € 1350 Nonmember
Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.

Survivor: the FDA 510(k) Program Edition

23 February 2023 - 24 February 2023

€ 1155 Member | € 1350 Nonmember
In this two-day, in-person workshop, you will gain an understanding of the 510(k) program and strategies to help obtain a positive clearance decision.

 

Location

Holiday Inn Munich – City Centre

Hochstrasse 3
81669 München
Germany

Reservations:

A limited number of rooms is available at the rate of €139.00 + tax.

BOOK ONLINE or call: +49 89 48030

Holiday Inn Munich

Vaccination Requirement

RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test 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.

Be Well Policy

Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site in Rotterdam, you will reconsider your participation at the event. To help ensure your personal safety and comfort during the workshops, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.

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