RAPS Workshop: Risk Management for Medical Devices

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.

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

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 [email protected]. 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 [email protected] 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 [email protected].

Speaker

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