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ISO 14971 Risk Management Training

Practical Medical Device Risk Management Training

Our training combines regulatory expectations with practical industry examples to support organisations developing, manufacturing or maintaining medical devices.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

Course Overview

ISO 14971 is the internationally recognised standard for the application of risk management to medical devices. Effective risk management is a core requirement under EU MDR, UK MDR and global regulatory frameworks.

This training course provides participants with a clear understanding of practical regulatory expectations and core methodologies to help organisations strengthen compliance and improve overall product safety.

Core elements covered include:

Risk management terminology
Risk analysis methodologies
Hazard identification
Risk evaluation and acceptability
Risk control implementation
Benefit-risk analysis
Residual risk evaluation
Production and post-production activities
Risk management documentation

Who Should Attend?

This course is tailored specifically for the following roles and teams:

Medical device manufacturers
QA/RA professionals
Design and development engineers
Project managers
Start-up companies
Product development teams
Compliance professionals
Individuals new to ISO 14971

What You Will Learn

By the end of this course, participants will understand:

The structure and purpose of ISO 14971:2019
How risk management applies throughout the device lifecycle
How to identify hazards and hazardous situations
Methods for estimating and evaluating risk
How to establish risk acceptability criteria
How to implement and verify risk controls
How to perform benefit-risk analysis
How post-market information feeds into risk management
Regulatory expectations under EU MDR and UK MDR
The relationship between ISO 14971 and IEC/TR 24971

Course Topics

Introduction to Risk Management

Risk management principles
Regulatory expectations
Lifecycle approach

ISO 14971 Structure & Requirements

Key clauses of ISO 14971
Scope and application
Definitions and terminology

Risk Analysis

Intended use and reasonably foreseeable misuse
Hazard identification
Hazardous situations
Sequence of events
Risk estimation methods

Risk Evaluation

Risk acceptability
Severity and probability assessment
Risk matrices and scoring approaches

Risk Control

Inherent safety by design
Protective measures
Information for safety
Verification of controls

Benefit-Risk Analysis

Evaluating residual risks
Acceptability decisions

Production & Post-Production

Complaint handling
Vigilance and PMS feedback
Updating the risk management file

Risk Management Files

Risk management plans
Risk management reports
Maintaining the risk management file

Course Format

Live online instructor-led training
Private company sessions
Group workshops
Customised training programmes

Training can be delivered remotely or tailored specifically to your organisation’s products and processes.

Course Duration

Typical duration structures:

Half-day: Introductory course
Full-day: Detailed practical workshop

Custom delivery lengths are explicitly available for private corporate training paths.

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Certification

Participants will receive a formal Certificate of Attendance upon successful completion of the training course.

Why Choose Patient Guard?

Practical industry-focused training
Experienced medical device regulatory professionals
Training aligned with EU MDR and UK MDR expectations
Real-world risk management examples
Support for manufacturers and start-ups
UK and EU regulatory expertise

Individual Training Options

Introductory

Half-Day Training Course

£495 / per person

What's included:

Live online instructor-led training
Training materials
Certificate of Attendance
Opportunity for Q&A with the trainer

Comprehensive

Full-Day Training Workshop

£695 / per person

What's included:

Extended practical workshop sessions
Real-world risk management examples
Interactive discussions
Training materials
Certificate of Attendance

Corporate & Private Team Training

Patient Guard provides bespoke private training sessions explicitly tailored to your organisation’s devices, technologies, and internal Quality Management System (QMS) processes.

Investment

From £2,500 / day

Ideal for:

Medical device manufacturers
Start-ups and innovators
Internal QA/RA teams
Design and development teams
Organisations implementing ISO 14971

Bespoke pricing options depend on:

Total number of attendees
Required training duration lengths
Specific technical customisation pathways
Preferred interactive delivery format

Delivery Format

All sessions are formatted for maximum interaction and accessibility:

Live online & instructor-led
Fully interactive and practical modules
Available globally across international time zones

Custom on-site or dedicated corporate physical venue sessions are optionally available upon request.

Group Discounts

Do you have multiple attendees looking to sit the course from the same organisation?

Discounted tier scaling options are available for unified corporate team bookings.

Please reach out to Patient Guard directly for group booking pricing structures.

Request Pricing & Availability

Get in touch to check upcoming open course schedules, secure corporate group dates, or request an explicit customized quote for your team.

Contact Patient Guard

FAQs

Is this course suitable for beginners?

Yes. The course is designed to support both beginners and experienced professionals involved in medical device risk management.

Does the course cover EU MDR requirements?

Yes. The course explains how ISO 14971 supports compliance with EU MDR and UK MDR risk management expectations.

Is this training live or recorded?

Training is currently delivered live online with instructor support. Private sessions can also be arranged.

Can training be customised for our company?

Yes. Patient Guard can provide customised private training tailored to your devices, technologies and internal processes.

      
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   Nafiul Shelim 
 9 days ago
 
 
 Trustindex verifies that the original source of the review is Google. I worked with Eleanor Shackleton, from Patient Guard, for the purpose of MDR, CE and UKCA marking. Her diligence, and knowledge in clinical and regulatory requirements for medical device software was critical for us. Would highly recommend
  
 
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   Jay Verma 
 34 days ago
 
 
 Trustindex verifies that the original source of the review is Google. I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
  
 
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   Munna P 
 87 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey.

Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues.

A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track.

I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives.

Thank you again to the entire Patient Guard team for being such reliable partners.
  
 
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   Peter Reeve 
 114 days ago
 
 
 Trustindex verifies that the original source of the review is Google. STEPPER design, manufacture & distribute eyewear across the globe.  With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did!

They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble.

We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories.

Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
  
 
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   Derek Timm 
 114 days ago
 
 
 Trustindex verifies that the original source of the review is Google. For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd   The staff are fantastıc  nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them  Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
  
 
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   BMSCriticalCare 
 151 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Great service, very helpful and always willing to answer any questions we have,
  
 
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   Thomson Software 
 822 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner.  He was friendly, patient and willing to go the extra mile.  Excellent service.
  
 
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   Hannah Maddison 
 925 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Fantastic, knowledgeable team that are always there to help.  My appointments have always been booked in very promptly and have always ended with all my queries resolved.  I have found the team very flexible and their breadth of knowledge is second to none.  Patient Guard are without doubt my go-to for all the regulatory aspects of my medical device role.
  
 
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   Richard Crow 
 960 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Patientguard are an excellent source of Medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with Technical Files all the way through to using their ISO Templates to implement our ISO 13485 system.
  
 
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   George Kitching 
 963 days ago
 
 
 Trustindex verifies that the original source of the review is Google. David Small and PatientGuard have been extremely helpful and supportive in assisting us with producing and updating our Technical File and Appendices for MDR certification.
  
 
 
  
 
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