Live Webinar

Risk Management Integration: ISO 14971 in a QMSR World

This course equips teams to build and maintain an ISO 14971-based Product Risk Management File that actively drives design choices, risk controls, and validation priorities under QMSR expectations. Participants leave with practical templates and a repeatable review approach so risk evidence remains usable for CAPA, failure investigations, and cross-functional training instead of drifting into a one-time document.

   04 March 2026    |       11.00 AM Eastern Time (US/Canada)    |       04.00 PM GMT    |       90 Minutes    |       MD1858

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Risk Management Integration: ISO 14971 in a QMSR World

This course equips teams to build and maintain an ISO 14971-based Product Risk Management File that actively drives design choices, risk controls, and validation priorities under QMSR expectations. Participants leave with practical templates and a repeatable review approach so risk evidence remains usable for CAPA, failure investigations, and cross-functional training instead of drifting into a one-time document.
    John E. Lincoln    |         90 Minutes    |       MD1858
 

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

LIVE - SINGLE

US $290
ONE participant (viewer) – Live session
PLUS Complimentary Streaming access for 2 month

CORPORATE - LIVE

US $990
Up to 10 participants – Live session
PLUS Complimentary Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Registration to this course includes:

  • Presentation Handout & Templates
  • Certificate of Completion
  • Trial access to TalkFDA Subscription
  • TalkFDA Members-only Community

SINGLE ACCESS

US $290
ONE participant (viewer) – Streaming access for 2 month

CORPORATE ACCESS

US $990
Up to 10 participants – Streaming access for 2 months for each attendee

TalkFDA Membership Benefits

Be a part of the exclusive community
Explore how membership complements your learning

Why take this course?

Risk management expectations for medical devices are shifting under the Quality Management System Regulation, with stronger emphasis on using product risk management to guide design, production, and validation activities. Manufacturers are expected to recognize that every device use carries risk and to document reasonable risk controls based on state of the art. When hazard analysis lacks rigor, organizations lose visibility, mis-prioritize resources, and increase exposure during clearance, approval, and post-market scrutiny.


This program focuses on building, updating, and applying a Product Risk Management File and Report so it operates as a working reference rather than a static deliverable. The content ties ISO 14971 methodologies to day-to-day execution: how hazards are identified, how hazardous conditions are framed, and how documentation is structured for review and reuse. Procedures and suggested templates are addressed to support consistent team involvement, governance, and maintenance over the product lifecycle, with risk thinking extending into the broader QMS.


Methods emphasized include product hazard analysis and structured tools such as design, process, and use-related FMECA and Fault Tree Analysis, along with guidance on who participates, when to review, and how to keep the file current. The outcome is a maintained “living document” that stays in the loop for CAPA, root cause and failure investigation, validation prioritization, and training, reflecting audited, field-tested practices used in FDA and Notified Body contexts.

  • Build a risk file that stays usable after design reviews:

    Many risk files meet a submission need yet fail to support day-to-day quality decisions. This course shows how to structure the Risk Management File and Report so hazards, hazardous conditions, and risk controls can be referenced quickly when decisions are needed. The result is clearer prioritization when resources are tight, better continuity across design, process, and production functions, and fewer gaps when risk rationale must be explained during internal reviews or external scrutiny.


  • Apply FMECA and Fault Tree Analysis with the right team involvement:

    Risk tools only work when they are executed consistently and reviewed by the right functions at the right times. The program provides practical guidance on organizing team roles, timing, and review cadence while using product hazard analysis, design/process/use FMECA, and Fault Tree Analysis as intended. Participants gain a clearer method for linking failure modes and causal paths to documented risk controls, creating analysis that holds together across development, manufacturing, and lifecycle updates.

  • Keep risk management “in the loop” for CAPA, investigations, and validation focus:

    Risk documentation becomes higher value when it is routinely used to steer corrective actions, failure investigations, and validation priorities. This course lays out how to integrate the completed risk file into CAPA and root cause processes, and how to maintain it as a living document as products and processes change. Participants gain a workable maintenance approach that preserves visibility, supports training, and reinforces a risk-focused QMS mindset under QMSR.

Key Areas Covered

ISO 14971:2019 updates for medical devices, including key changes from the 2007/2009 editions and linkage to ICH Q9
Risk management expectations under QMSR (21 CFR 820) and the emphasized role of ISO 13485 within the device quality system
Product hazard analysis with meaningful definition of hazards, hazardous conditions, and documentation expectations
Design, process, and use-related Failure Mode, Effects and Criticality Analysis and how results are organized for review
Fault Tree Analysis use and how causal paths are documented and reviewed alongside other risk tools
Suggested templates for Risk Management File/Review, FMECA, and FTA to support consistent execution
Team participation model: who is involved, when involvement is needed, and how reviews are run
Using the completed risk documentation as a working reference for CAPA, investigations, validation prioritization, and training
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