ISO 14971: Risk Management for Medical Devices

Description

ISO 14971: Risk Management for Medical Devices

What is ISO 14971:2019?

The ISO 14971 standard covers the Application of Risk Management Principles to Medical Devices.

• ISO 14971:2019 contains guidance for best-practice risk management for medical devices
• It applies to all types of medical devices in all product classes, including in-vitro diagnostic (IVD) devices and medical software

Why is compliance with the ISO 14971 Medical Device standard so important?

• Industry guidelines require medical device companies to adopt a risk-based approach in relation to their Quality Management System (QMS)
• A risk-based approach and risk-control strategies are required for the QMS
• ISO risk-management standards must be incorporated into management policies, processes, work instructions, procedures, and other quality control measures and quality checks

Quality Risk Management Across the Life Cycle of the Medical Device

Risk Management activities and controls must continue across the entire life cycle of a medical device to ensure product safety and performance.

• A risk-based approach must be maintained across the entire life cycle of the medical device
• This includes production and post-production monitoring of product safety information

QMS Audits (Medical Devices)

Understand what Regulatory Authorities expect during QMS audits

By completing this ISO 14971:2019 Medical Device (Risk Management) certificate training course, you will gain insight into what many Regulatory Authority Inspectors/Auditors expect in terms of compliance with this standard.

This course highlights the importance of applying risk management principles to medical devices, across the entire life cycle of the device, including for IVDs and medical software. It includes practical examples of risk management approaches.

Certificate Compliance Course

This Certificate Training Course helps learners understand ISO 14971:2019 risk management principles and standards for medical devices:

• The importance of risk management principles to medical device quality management and product safety/patient safety
• Why risk-based decisions and risk controls are crucial for establishing an effective Quality Management System (QMS)
• Hazards and Risks
• Sequences of events leading to hazardous situations
• Safety versus Harms (Risk Analysis methods)
• Risk Assessment processes
• Risk Management Plan Requirements and Residual Risk Acceptance Levels
• Estimating product misuse and user error
• Risk control strategies and risk evaluation tools
• Documentation requirements for risk management activities
• What needs to be included in your Risk Management File
• Personnel requirements for risk management activities
• Requirements for management reviews of production and post-production information
• Safety monitoring/post-market release surveillance
• Regional regulatory guidance for implementation of ISO 14971 principles and risk control measures

Medical Device regulations

ISO 14971 (Medical Device Risk Management) training course

 

Benefits of compliance training related to ISO 14971 standards

Completion of this ISO 14971 QRM compliance training course:

• Is suitable for a variety of businesses that manufacture, service, import, export and/or distribute Medical Device products
• Is available in a self-paced, fully online format as a Training Certificate Course
• Will help personnel, contractors and suppliers understand Quality Risk Management (QRM) principles for Medical Device products covered by the ISO 14971 standard 

Is your team compliant with medical device industry standards?

• Ongoing, documented regulatory compliance training is an expectation in the therapeutic goods industry
• Understanding ISO standards for risk management will help your team develop a compliance culture
• Once you (or other team members) pass the Final Assessment, a Certificate of Completion is available to download/print for your personnel file, training record file, and/or to attach to your CV/resume or medical device industry job applications
• One user per licence

Benefits of adopting blended learning approaches

eLearning plus onsite training and supervision

• Online courses are best combined with onsite training (and product-specific training)
• These courses help introduce and/or reinforce regulatory compliance knowledge and what’s expected during a compliance Audit
• Regulatory training reinforces a compliance culture and reminds employees of essential QMS requirements and recordkeeping requirements
• Regulatory compliance courses are not intended to replace onsite, product-specific training
• Learners should thus also be trained to follow all relevant ISO standards & GMP guidelines relevant to their:
  • Product classification
  • Distribution regions/jurisdictions
  • Roles and responsibilities

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Medical device regulations and guidance

ISO 14971: This online regulatory compliance training course is suitable for a worldwide audience.

This certificate risk management training course for Medical Devices is ideally suited for:

• Innovators, medical device designers, medical device production design engineers
• Founders/Owners/CEOs of medical device companies and medical software vendors
• Quality Managers & Quality Associates in Medical Device and Medical Software businesses
• Personnel and Contractors & Medical Device and Medical Software Service Providers
• Industry Service Providers and Software Support personnel/contractors
• Production Managers and Equipment Service Contractors
• Designers, repair/service providers, distributors
• Quality Testing personnel or third-party auditors
• Auditors and GMP Compliance Inspectors
• Quality Team Leaders and Quality Management Associates
• Post-Marketing Surveillance Personnel or contractors
• Packaging and Labelling Operators and Logistics Managers
• Manufacturing personnel
• Other personnel working in a GMP/cGMP environment
• Software designers and medical device/digital healthcare software update support personnel
• QMS documentation specialists
• Risk Assessors and Quality Managers
• Auditors/Regulatory Authorities

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Earn your industry training certificate in ISO 14971 to add to other popular Medical Device and Pharmaceutical Industry education topics. 

You should ideally complete the following training course prior to completing the ISO 14971 risk management course:

• ISO 13485 QMS – Regulatory compliance guidance training course.

This training course covering risk assessments and risk controls for medical devices is ideal to complete along with the Complaints Management course, the Deviations and Non-Conformances Management course, and the CAPA systems training course.

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Course Overview

This online GMP training course will answer common FAQs about ISO 14971 requirements for adopting a risk-based approach to your Quality Management System (QMS) policies, procedures, documentation, training programs, self-inspections, audits, management reviews, validation requirements, quality controls and risk controls.

• ISO 14971 is a widely accepted standard for applying risk management principles to medical devices
• The standard helps manufacturers of medical devices to apply risk management strategies and controls to their medical devices (including IVDs and medical software products) across the life cycle of the devices

Completing this Certificate GMP training course in ISO 14971 risk management principles and risk controls will help your team learn what’s generally expected by Regulators in terms of the application of risk management principles.

It is recommended that learners also have adequate training in other regulatory compliance requirements, such as:

Root cause analysis and CAPA documentation requirements

Data Integrity

Complaints Management

This course includes examples of ISO 14971 guidance from Regulatory Authorities from:

• European Union (EU) European Medicines Agency
• US FDA – Food and Drug Administration
• Australian TGA  – Therapeutic Goods Administration
• UK MHRA – Medicines and Healthcare Products Regulatory Authority
• China
• Canada Health (CA)

Purchase this course online, and start your training today! Be sure to read the FAQs so you know what to expect.

Medical device risk management

This self-paced ISO compliance training course explores ISO 14971 standards for the application of risk management principles to medical devices and to organisational policies, processes and procedures.

Course content is based on publications from ISO, the FDA, TGA, MHRA and other regulators as well as insights from our team of regulatory compliance experts for medical device organisations.

• The training course will assist personnel in understanding Regulatory expectations for adopting a risk management approach to their Quality Management Systems.
• It is ideal for medical device manufacturers and service businesses, including distributors.
• This course will assist personnel who may be involved with aspects of quality control including documentation preparation, compliance training, self-inspections, and regulatory audits.
• If you develop, design, manufacture, import, service, repair, distribute, update, or are otherwise involved with Medical Devices, this course should be part of your Regulatory Compliance Training program. 
• This course should be completed along with the ISO 13485 QMS regulatory guidance training course.

How to complete this course.

• Add the course to your basket and complete your purchase.
• Remember, the course fees are listed in US Dollars.
• Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised.
• Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and @pharmout.net”.

With online training for ISO14971, product recalls, CAPA implementation and other GMP education topics, you can mix and match GMP education courses with a training bundle package.

Alternatively, you can purchase a single course or just a few of the courses you need for ‘just-in-time’ learning.

• Note: one learner, one cGMP course completion Certificate per course purchase.
• The learner will have 12 months’ access to the course and a downloadable online CAPA training certificate of completion.

Bundled training options let you ‘mix and match’ standard GMP compliance training courses and/or assign courses to different employees when required (enabling ‘just in time’ GMP training). All successfully completed courses provide learners with a time-dated GMP Training Certificate for successful completion of that particular GMP education topic.

Note: All course prices are in US dollars.

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Further Reading: Medical Device Industry Resources

Recommended training courses to ensure compliance with ISO 14971 and other medical device standards and regulations include the following GMP education courses.

ISO 13485 QMS regulatory guidance training course.

CAPA training presentation (live-streamed)

Deviations and Non-Conformances (Management) in cGMP environments

Complaints Handling and Recalls (available now)

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• Click here for Deviation Management examples and templates.
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