Medical Device Risk Management
Classes offered onsite at your facility. Contact us for additional training options.
A 3-day course covering the multi-disciplinary nature of the medical device and IVD risk management process and the techniques you can employ to succeed. Learn risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), and the creation of risk management plans, reports and files.
What will you learn?
Intensive and comprehensive discussion of FDA, Notified Body, and auditor’s perspective, precedents & priorities for every topic presented in the course.
Enumerate the fundamental documentation requirements of ISO 14971:2012 (Medical Devices – application of risk management to medical devices).
Develop an understanding of Risk Management as part of the product and process development cycle by defining a hazard, levels of risk, types of harm, and risk controls,
Prepare a Hazard Analysis including hazards, hazardous situations, harms, and understand risk estimation.
Perform a HACCP (Hazard and Critical Control Points) analysis as a qualitative process hazard analysis for process risk management for any process,
Assess the application and results that critical tools of quality such as a Failure Modes and Effects Analysis and Fault Tree Analysis can provide,
Prepare a Risk Management Plan in a device, a pharmaceutical product, a diagnostic product, or a process, which describes the tasks involved in successfully leading an ISO Quality System implementation project from start-up through Registration.
Apply structured qualitative and quantitative risk management concepts and tools leading to a documented Risk Management Plan and Risk Management File that can be used in any due diligence for reducing risk in product, process or service development.
Compose and document mitigations to risk in a suitable regulatory format,
How to avoid vagueness and incompleteness in your Risk Management File.
Is it for you?
This course discusses how risk management is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries.
Lectures and workshops delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis (FTA), failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System.
Utilize a current on-market medical device with practical templates (Risk Management Plan, Hazard Analysis Worksheets, Fault Tree Analysis, Use/Application, Design and Process FMEAs, Risk Management Report, and more) in engaging, interactive workshops.
By the end of the course, you'll be able to conduct risk management for a variety of products, processes and services within the biomedical industries and beyond.
Course Tuition Includes
Instructor-led three-day course
Course notebook with all slides
Electronic version of all templates
Certificate of Completion
Tips and advice on being highly effective in the FDA regulated industry
One hour free practical consulting on your project
Sign-In 9:00 a.m.
Morning Session 9:00 a.m. - 12:30 p.m.
Lunch 12:30 - 1:30 p.m
Afternoon Session 1:30 - 5:00 p.m.
Cancellation and Refund Policy
Full refund if you cancel the training class thirty (30) days in advance of the class starting date.
Fifty (50)% refund if you cancel the training class within thirty (30) days of the class starting date.
No refund if you cancel within fourteen (14) days of the class starting date.