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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Learn how recent changes to the regulation of healthcare products in the EU will impact you as a regulatory professional.
In light of the COVID-19 pandemic, the RAC Board has elected to offer online testing with live online proctoring this summer.
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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
This workshop is currently sold out. If you would like to receive an email notification when this workshop is offered next, please complete the form at https://raps.realmagnet.land/samd-april-2020-lead-gen.
In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual event. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. This workshop will review the current and evolving regulatory requirements globally including the EU and US for software as a medical device (SaMD). Issues to be addressed include how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under global 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.
Registration Closes: 13 April 2020 Refund Deadline: 16 March 2020*
*Please see the cancellation policy below.
RAC Credits: 12 (Upon attending and completing the program)
Registration to 16 March 2020 RAPS Members: $800 Nonmembers: $900
Registration from 17 March to 13 April 2020 RAPS Members: $900 Nonmembers: $1,000
NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.
Program Schedule
15 April 2020 (9:00am–5:00pm)
16 April 2020 (9:00am-5:00pm)
NOTE: The agenda may vary based on changing requirements.
Faculty Pat Baird, senior regulatory specialist, Head of Global Software Standards, Philips
Lena Cordie, president, Qualitas Professional Services, LLC
Michelle Jump, Medical Device Security, MedSec
Royth Von Hahn, vice president of medical health services, TUVAM
Cancellation
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.
Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.
Proof of Attendance RAPS will send an electronic letter or a certificate of attendance upon request.
Questions Call RAPS Solutions Center at +1 301.770.2920, Ext 200
Registration Form If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Program Contact Nichelle Sankey nsankey@raps.org +1 301 770 2920, Ext 291