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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Are you struggling to understand the clinical evaluation requirements under the EU MDR?
This 16-hour training course will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system, and insights into the common pitfalls.
This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.
Mar 15, 2023 – Jun 11, 2023: Regular $1125 Member | $1290 Nonmember
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures and exercises requiring synthesis and/or application of concepts are incorporated into the activity.
This course is recommended for anyone involved in implementing or maintaining a clinical evaluation file.
Rod BeuzevalSenior Regulatory Expert
Rod Beuzeval brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices. Beuzeval’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Beuzeval has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP, and GDP.
Beuzeval’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients in updating their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP, and QMS systems.
Beuzeval holds the prestigious Regulatory Affairs Certification (Global Scope) from the Regulatory Affairs Professionals Society and is a Lean Sigma Green Belt. Beuzeval has worked in the medical device and pharmaceutical industry for over 23 years, including time spent in some of the largest medical device and pharmaceutical manufacturers.
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 email@example.com. RAPS is unable to accept cancellations by phone.
To transfer a registration, email firstname.lastname@example.org with the event title, name of the original registrant, and contact information for the new attendee.
A certificate of attendance can be downloaded
from the RAPS Learning Portal
following the event.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email email@example.com.