As medical devices continue to grow in complexity, effectively identifying and controlling risks has become more critical than ever to ensure patient safety. At this interactive workshop, delivered across four half days, we will explore key concepts of the ISO 14971 standard, providing you with a deep understanding of key requirements for risk management and how they integrate into other standards and regulations. Whether you are new to medical devices or looking to strengthen your expertise, this course has everything you need to confidently implement ISO 14971.
Registration Fees & Deadlines
Present – 17 November 2025: Member $1,125 | Nonmember $1,290
Learning Objectives
- Describe why ISO 14971 exists and how it is structured
- Understand the impact of key terminology throughout ISO 14971
- Establish processes and documentation for an effective risk management system
- Develop gold standard techniques that support risk analysis
- Understand what the regulators are looking for in your technical documentation
- Create a robust benefit risk statement
- Understand how post market surveillance and other processes impact risk
Who Should Attend?
There are no formal pre-requisites required for this course. This course applies to anybody that requires a practical understanding of risk management.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Time | Topic |
Online Self-Paced
(Pre-Course) | - Introduction to ISO 14971:2019
- Key terminology
|
Day 1 | - The impact of key terms
- Risk management process overview from plan to report
- Links to other processes
- Documenting your Risk Management File (RMF)
|
Day 2 | - Writing the Risk Management Plan (RMP)
- Establishing risk acceptability criteria
- Identifying hazardous situations
- Defining harm
- Estimating and evaluating risk
|
Day 3 | - Methods of controlling risk
- Benefit-risk analysis
- Evaluation of overall residual risk
- Writing your risk management report
- Production and post-production activities
- Risk management tools and methodology
|
Day 4 | - Guidance document TR 24971
- Other key regulations and standards
- Common pitfalls of risk management
- Notified body expectations
|
Speakers
Rod Beuzeval, RAC
Principle Trainer, Leap Compliance
Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices. He has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers. Rod’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. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP. Rod’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 update 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.
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org