Participants will explore how risk planning, risk assessment, benefit-risk thinking, and production/post-production activities translate into the warnings, precautions, contraindications, training requirements, and residual risk disclosures expected under GSPR 23 and current state of the art expectations, including the FDA Risk Assessment process.
The workshop focuses on the practical realities of EU MDR/UKCA and FDA review, including common deficiencies identified by Notified Bodies, weak traceability between risk management file (RMF) and labeling, and frequent gaps in risk control implementation and residual risk communication.
Through hands-on exercises, live review scenarios, and practical examples, attendees will learn how to:
- structure compliant risk management plans;
- build defensible hazard-to-harm logic;
- assess risk control effectiveness;
- generate appropriate Instructions For Use (IFU) and labeling outputs,
- and internally review RMFs, labels, and IFUs using Notified Body (NB)-style expectations.
The course is intended for regulatory, quality, clinical, and R&D professionals involved in risk management, technical documentation, labeling, EU MDR/UKCA compliance activities and FDA QMSR.
Learning Objectives
Participants will learn how to:
- Understand NB expectations for EU MDR/UKCA risk management documentation and related IFU/labeling outputs;
- Build and maintain ISO 14971-compliant risk management plans and assessments throughout the device lifecycle;
- Apply practical hazard–hazardous situation–harm logic and benefit-risk thinking;
- Evaluate whether risk controls and residual risks are adequately addressed;
- Translate risk controls into compliant IFU and labeling content aligned with GSPR 23 and state of the art expectations;
- Identify common EU MDR/UKCA deficiencies and perform practical self-review of RMFs, IFUs, and labeling using NB-style review approaches; and
- Understand expectations from FDA about QMSR, systemic evaluation areas and other relevant topics.
Agenda
8:30 – 9:00 AM Registration & Breakfast
9:00 – 10:00 AM Module 1: Risk Planning under ISO 14971 & EU MDR Expectations
Topics:
- Purpose and structure of the Risk Management Plan;
- Notified Body (NB) expectations for Risk Management planning under EU MDR/UKCA;
- Defining scope, intended purpose, users, environments, and interfaces;
- Risk acceptability criteria and state of the art considerations;
- Production and post-production feedback requirements; and
- Common NB findings and deficiencies
Workshop Exercise:
- Build a simplified Risk Management Plan from intended purpose;
- Identify missing or weak planning elements; and
- Review whether the plan supports EU MDR lifecycle expectations
10:00 – 10:10 AM Break
10:10 – 11:30 AM Module 2: Practical Risk Assessment & Benefit-Risk Evaluation
Topics:
- Hazard - hazardous situation - harm logic;
- Identifying foreseeable misuse and sequence of events;
- Evaluating severity and probability;
- Risk controls and verification of effectiveness;
- Residual risk and benefit-risk evaluation; and
- Common weaknesses seen during NB review
Workshop Exercise:
Participants review a mock risk assessment and identify:
- weak hazard logic;
- unsupported risk controls;
- poor traceability;
- inadequate residual risk evaluation; and
- missing benefit-risk rationale.
11:30 – 11:40 Break
11:40 – 12:40 Module 3: IFU & Labeling Outputs from Risk Management
Topics:
- Translating risk controls into:
- Warnings;
- Precautions;
- Contraindications;
- Training requirements; and
- Residual risk disclosures
- Relationship between RMF and GSPR 23;
- State of the art expectations for labeling and IFU;
- Consistency between:
- RMF;
- IFU;
- Labeling;
- Clinical Evaluation Report (CER)/Post Market Surveillance (PMS) references; and
- Marketing claims.
- Common IFU deficiencies under EU MDR/UKCA.
Workshop Exercise:
Participants review IFU and label excerpts and assess:
- which risks are being mitigated;
- whether wording is adequate;
- whether residual risks are appropriately disclosed; and
- whether an NB would likely challenge the content.
12:40 – 1:15 Lunch / Networking Break
1:15 – 2:00 Module 4: Integrated NB-Style Review Workshop
Capstone Exercise:
Participants perform a simplified NB-style review of:
- A Risk Management Plan;
- RMF excerpts;
- IFU/labeling outputs; and
- Selected post-market feedback examples.
Participants identify:
- inconsistencies,
- unsupported claims,
- weak residual risk communication,
- missing traceability,
- and EU MDR/UKCA vulnerabilities.
2:00 – 2:10 Break
2:10 – 3:30 Module 5: FDA & QMSR Risk Management
- Key Expectations of QMSR Risk Management;
- Core Risk Framework Components;
- Expanded Inspection Authority; and
- Systemic Evaluation Areas
3:30 – 3:45 Q&A & Closing
3:45 – 5:00 Networking Reception With Your SGS Experts
Location
Sheraton Minneapolis West Hotel
12201 Ridgedale Drive
Minnetonka, Minnesota 55305
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
