Advanced Risk Practitioner for Medical Devices

Advanced Risk Practitioner Training (Medical Devices) is for anyone who wants both a comprehensive overview of the international standard for risk management for medical devices, and to acquire the best practice skills to readily apply the knowledge and tools successfully within their organization.

Our blended learning course is a hybrid approach where you first complete eLearning modules on the underlying theory that better prepares you in advance of attending Live Classes with an Instructor where Learners will work with case studies & scenarios that help deepen the understanding of the requirements, and applying the tools & techniques in a real life context.

Why Choose Comply Guru?

Industry-Leading Blended Methodology

Learn from Anywhere

More Flexibility & Less Downtime at Work

Live Workshops led by Experienced Practitioners

Better Prepared In Advance of Live Workshops

Course Snapshot

Approved By

Comply Guru

Duration

18hrs

Teaching Format

Blended Learning

Delivery Options

Virtual or In-Person

Language (s)

English

Price

In-Company Groups

Why Choose Comply Guru?

Industry-Leading Blended Methodology

Learn from Anywhere

More Flexibility & Less Downtime at Work

Live Workshops led by Experienced Practitioners

Better Prepared In Advance of Live Workshops

Course Structure Explained

Detailed Breakdown & Agenda

Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.

Time	Topic
75mins eLearning	Module 1: Introduction to Risk Management Risk Management and Product Lifecycle Risk Perception Introduction to ISO 14971 ISO 14971:2019 Key Changes Structure of ISO 14971 Key Terminology Medical Device Regulatory Framework Product and Process Standards
75mins eLearning	Module 2: Risk Management Planning Clause 4 Overview Risk Management Process Risk Acceptability Policy Risk Management Process Review Risk Management Team Competency Expert Training Risk Management Plan Risk Management File
90mins eLearning	Module 3: Risk Assessment Risk Assessment Overview Risk Analysis Process Intended Use Reasonably Foreseeable Misuse Safety Characteristics Hazards and Hazardous Situations Types of Hazards Sequence of Events Random & Systematic Faults Risk Estimation Risk Evaluation Risk Analysis Tools Preliminary Hazard Analysis (PHA) Fault Tree Analysis (FTA) Failure Mode Effect Analysis (FMEA) Hazard and Operability Study (HAZOP) Hazard Analysis and Critical Control Point (HACCP)
60mins eLearning	Module 4: Risk Control Risk Control Risk Reduction Risk Control Analysis Role of Standards in Risk Control Implementation Residual Risk Evaluation Benefit-Risk Analysis New Risks Risk Control Completeness Overall Residual Risk Disclosure of Significant Residual Risks
60mins eLearning	Module 5: Risk Management Review and Update Risk Management Review Production and Post-Production Activities Information Collected Information Review Actions Relationship between ISO 13485 and ISO 14971 ISO 14971 and Design & Development
90mins eLearning	Module 6: ISO/TR 24971 ISO/TR 24971 Purpose and Structure ISO/TR 24971 Annexes Annex F Security Risks Annex H IVD Medical Devices
40mins	Eligibility for Live Workshop Exam 40 MCQ-based eAssessment with 70% or higher required to be eligible to attend the live workshop on day 2

Time	Topic
9:00am - 5:00pm	1-day of Practical Workshops working with Practical Case Studies covering: Ready to Use Risk Management Tools & Techniques Preliminary Hazard Analysis (PHA) FMECA HAZOP Fault Tree Analysis (FTA) Application of Risk Management to Software Risks Practical Implementation Tools & Techniques Application to the Product Lifecycle

Time

Topic

9:00am - 5:00pm

1-day of Practical Workshops working with Practical Case Studies covering:

Ready to Use Risk Management Tools & Techniques
Preliminary Hazard Analysis (PHA)
FMECA
HAZOP
Fault Tree Analysis (FTA)
Application of Risk Management to Software Risks
Practical Implementation Tools & Techniques
Application to the Product Lifecycle

Course Overview

Advanced Risk Practitioner

Who Should Attend

This course is aimed at anyone working in the medical device sector that wants to master risk management based on ISO 14971, including:

Design & Development personnel
Quality / Engineering / Technical / Production personnel
Regulatory affairs
Internal / Lead / Supplier Auditors

Course Certification

Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

What Are The Entry Requirements

Before completing this course, each Learner is recommended to have the following prior knowledge:

The fundamental concepts and principles of risk management as it applies to medical devices
The commonly used risk terms and definitions (see ISO 14971)
A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course

How You Are Assessed

In order to successfully complete this course, each Learner will need to:

Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
Fully attend the Live Instructor Workshops as 100% attendance is required
Obtain 70% or higher in the graded assessments during the Live Instructor Workshops

What Are The Technology Requirements

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Why Choose Comply Guru

About our Advanced Risk Practitioner Training

Learn about how our Training is leading the industry for innovation & learning effectiveness

Why Choose Blended Learning

Frequently Asked Questions

Can I transfer my place to a colleague?

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.

Do we offer group discounts?

Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.

How long does it take to complete the course?

This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.

How long will I have access to the course?

The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.

What if I fail the final assessment, what happens?

Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).

What payment methods do we accept?

The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com

What technology is used for this training?

When and where do I get my course certificate?

Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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