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Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Staying compliant in Post-Brexit Great Britain requires a thorough understanding of the guidances issued by the MHRA
and careful navigation of changing regulatory landscape. Since the EU MDR and EU IVDR don’t automatically apply, RA
professionals need to thoroughly understand the new regulatory framework route to market using Great Britain’s UK CA
mark or UK NI mark and how new regulations vary across Britain’s provinces. This program will cover how to interpret the numerous MHRA guidance documents and more after the Brexit transition period.
Described as a think tank, where collaboration rules, Solutions Circles are where regulatory professionals will be able to
come together with the highest form of collaboration. Popularized at RAPS Convergence, Solutions Circles allow you to
bounce ideas off colleagues and examine regulatory challenges.
5 February 2021 – 23 March 2021: Member $160 | Nonmember $175
Kim Trautman, M.S. Executive Vice President, Medical Device International Services
Kim Trautman is an experienced Medical Devices and In Vitro Diagnostics Executive Vice President with over 30 years of
experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with
Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated
history of working collaboratively with industry, regulators and patient groups for the betterment of public health.
Executes several medical device regulatory services and developed a formal Education/Training business. Established an
Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU
Robert van Boxtel, Medical Device Project B.V.
Robert van Boxtel is Principal Consultant and management team member at Medical Device
Project B.V. in the Netherlands. For more than 10 years, he supports the medical device
industry with QA and RA related consultancy, focusing on the EU and USA. Additionally, he
provides training to the industry, Notified Bodies and Competent Authorities on EU MDR, ISO
13485, Risk Management, auditing etc. He is hired by the Dutch Standards Institute (Royal
NEN), as SME for training on ISO 13485 and MDD/MDR. Furthermore, he participates in
TC210 discussions on quality management systems, risk management, PMS and is member of
the Dutch horizontal standards committee.
Robert is Board Member of both the RAPS Netherlands Chapter and the RAPS European
Before joining Medical Device Project B.V., he worked at KEMA Quality Notified Body (now Dekra Certification) and in
the medical device industry in several roles in design and production, both in the EU and the USA. As a result he has over
25 years of experience in the medical device industry.
Steve McRoberts, CPhys MInst, Chief Risk Officer (Technical) LumiraDX
Steve McRoberts has worked with medical devices and in vitro diagnostic products for more than 26 years as a test engineer, medical device designer, and regulatory and industry executive. He started his career in device testing and certification, and has conducted nearly 1,000 certification projects. McRoberts also was head of two different notified bodies covering the EU directives on devices and IVDs. He is an experienced auditor for ISO 13485 and medical devices regulatory QMS programs, including CMDCAS, European Notified Body, Japan 3rd Party Program and MDSAP. He was a member of the CMDCAS regulators forum from 2004 to 2015, helping to shape the Canadian regulatory program and transforming it to MDSAP. He has been an active contributor to numerous international working groups and technical committees. McRoberts has provided expert input, training and consulting on the development of medical device and IVD regulations to multiple national governments.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs
incurred due to cancellation.
All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept
cancellations by phone. Please specify the name of the person registered and event title.
Substitutions may be accepted with written approval from RAPS and must be submitted to email@example.com.
If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at