ISO 14971: Risk Management for Medical Devices
Course duration: Allow 2 to 3 hours to complete this course.
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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 GMP 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 standard important?
- GMP regulations and ISO guidelines require medical device companies to adopt a risk-based approach in relation to their Quality Management System (QMS)
- Risk-based decisions and risk-control strategies are required as part of the QMS
- ISO risk-management standards must be incorporated into management policies, processes, work instructions, procedures, and other quality control measures and quality checks
Risk Management Across the Life Cycle of the Medical Device
Risk management activities 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
Understand what regulatory authorities expect during QMS audits
By completing this ISO 14971:2019 certificate training course, you will gain insight into what Regulatory Authorities expect in terms of the application of risk management principles to medical devices, across the life cycle of a medical device, including for IVDs and medical software.
This Certificate Training Course covers the following ISO 14971:2019 principles of risk management:
- 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
Preparing your team for the application of Risk Management principles to Medical Devices.
Completing this ISO 14971 certificate training course (online)
- This ISO 14971 training course is suitable for any business that manufactures, services, imports, exports and/or distributes a Medical Device
- It’s available in a self-paced, online format
- Understanding ISO standards for risk management will help your team develop a compliance culture
- Once you 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 resume or medical device industry job application
Benefits of blended learning
- 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
Medical device regulations and guidance
ISO 14971: This training course is suitable for a worldwide audience.
This certificate ISO 14971 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
Earn your GMP training certificate in “ISO 14971” to add to other GMP education topics including deviations management, complaints management, and CAPA!
You should ideally complete the following training course prior to completing the ISO 14971 risk management course:
This newly-released ISO 14971 training course/presentation, 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.
Synopsis of the ISO 14971:2019 standard for medical device manufacturers
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:
Medical Device Products: Risk Evaluation FAQs
Completing this course will help you answer the following questions about risk management in the Medical Device industry:
- What types of medical device companies must comply with the ISO 14971 risk management standard?
- What types of records must be kept?
- What is the process for designing and implementing risk controls?
- Why is determining the Residual Risk Acceptance criteria critical for product safety and quality control?
- Who are the stakeholders in the medical device sector when it comes to assessing and managing risks?
- What are the documentation retention periods?
Learn about ISO 14971:2019 risk management principles for medical devices.
This fully online Certificate GMP training course is suitable for a global audience and for any type of regulated medical device.
To order, simply scroll up and “add to cart”, complete your purchase, and then check your email system for an email with your log-in details (search all mailboxes).
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
- 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.
- 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.
GMP industry and ISO 14975 compliance training experts
The course provides learners with a helpful training resource relating to internationally accepted standards and regulatory guidance for establishing and maintaining an effective Quality Management System for medical devices.
- This is one of our many GMP education topics eLearning courses available 24/7.
- It is a follow-up course to the other ISO standards training course(s) listed previously, as well as being a suitable follow-up training course to our Complaints Management courses and CAPA training courses for GMP personnel and Managers.
- Click here for a list of face-to-face courses delivered via Zoom, including CAPA (onsite training of large groups of personnel may also be available, where feasible).
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.
Do you need to train your personnel to follow GMP and CAPA procedures?
- If you need to train large numbers of employees on CAPA, complaints management, and/or Deviations and Non-Conformances Management in a GMP environment, contact us for a quote.
- You can alternatively order discounted GMP education topics/GMP training bundles.
- If you’re purchasing this course for yourself and your future career in the pharmaceutical industry, consider the customisable 4-bundle course packages.
Note: All course prices are in US dollars.
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.
About this Pharmaceutical Industry training course
- Completion of any of our online GMP courses will enable you to print your GMP topic Course Certificate — and earn a Credly badge for your social media channels.
- You can also attach your Certificate of Completion to your CV when applying for jobs in the pharmaceutical sector.
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”.
One user/per licence purchase (12 months’ access)
- This ISO 14971 education course (risk management/medical device regulatory compliance training) is available online, one user per licence.
- Course completion provides learners with a foundational understanding of planning and implementing an effective QMS for medical devices and medical device servicing, including medical device software updates and post-marketing surveillance.
- 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.
Allow 2 to 3 hours to complete this ISO 14971 eLearning training course including the online Final Assessment.
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.
Back to the online GMP training store.
Are your SOPs for deviation management out of date?
- Click here for Deviation Management examples and templates.
- Technical writers for SOPs are also available as PQS/QMS consultants/writers.