GHTF Quality System Risk Management Guidance

The Global Harmonization Task Force Study Group 3 issued: “Implementation of risk management principles and activities within a Quality Management System” dated May 20, 2005. The full guidance is at the link provided.

This document discusses risk management activities to be considered for each aspect of a quality system from Management Controls to Design Control through Production, Service, and CAPA.

Annexes A presents commonly used risk estimation rating tables including hazard and likelihood scales. SoftwareCPR continues to recommend that for software and other systematic (not random) errors that could be contributing factors to hazardous situations, likelihood be applied only after attempts to identify risk control measures. In other words the risk table in Annex A would be useful for residual risk evaluation after an initial attempt at risk control. SoftwareCPR believes using this table initially to determine if any risk control is needed can lead to higher risk then is reasonably practicable or in some cases acceptable.

Annex B presents a typical flowchart of risk management consistent with the concepts of ISO 14971. Again SoftwareCPR cautions against misuse of the initial risk evaluation as discussed in the preceeding paragraph.

The GHTF is a voluntary international group of representatives from medical device regulatory authoriities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. GHTF guidances are non-binding. FDA is an active participant in the GHTF.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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