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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Global regulatory agencies are adopting more digital solutions with the goal of efficiently processing more information, including solutions such as the EU EUDAMED, FDA eSTAR 510(k) program, and Chinese eRPS. The ultimate goal is to process a higher volume of submissions, while improving data quality and consistency in order to reduce agency costs, eliminate time-consuming administrative activities, and decrease cycle time for high-volume, complex regulatory submissions.
With government agencies increasingly adopting digital solutions, many MedTech companies still struggle with outdated, manual, word processing solutions that are administratively burdensome. Time-to-market is a critical competitive advantage and so is the ability to keep up with an ever-evolving regulatory landscape. For MedTech RA teams, digital transformation is key to both outcomes.
Learn how organizations can respond to the growing adoption of digital solutions by global regulatory agencies and how to process a higher volume of submissions while improving data quality and consistency.
2 March 2022 – 16 June 2022: Regular $175 member | $200 nonmember
After this program, participants will:
The agenda may vary based on changing requirements.
Instructors:
James Gianoutsos, Founder & CEO at Rimsys Regulatory Management Software
James Gianoutsos is a quality assurance and regulatory affairs professional with a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and postmarket surveillance of drug products and Class I, II and III devices. He has worked with products in a variety of clinical applications, including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. Gianoutsos has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD and CMDCAS requirements and standards, and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, design dossiers, technical files and INDs. He earned an MBA with a concentration in operations management and strategy from the University of Pittsburgh.
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 to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
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 raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance following the workshop.