ISO 14971: Risk Management for Medical Devices

Description

ISO 14971 Risk Management for Medical Devices:

Risk management is a core requirement for all medical devices and IVDs. This course introduces the principles and practical application of ISO 14971:2019, the international standard for risk management of medical devices throughout the product lifecycle.

This online course is ideal for professionals working in quality assurance, regulatory affairs, product development, and manufacturing within the medical device and IVD sectors. Whether you are new to risk management or seeking to deepen your understanding of ISO 14971, this course provides a clear and practical overview of compliance requirements.

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

What is ISO 14971:2019?

ISO 14971:2019 is the international standard titled:

“Medical devices — Application of risk management to medical devices.”

The ISO 14971 standard provides a systematic framework for manufacturers to identify, evaluate, control, and monitor risks associated with medical devices throughout their entire lifecycle, from design and development through to production, post-market use, and disposal.

Course Overview: Key Topics Covered

• Completing this course will provide you with insights into how medical device product risk is defined and controlled under the ISO 14971:2019 standard.
• In a convenient fully-online learning format, this course covers key risk management concepts such as hazard identification, risk estimation, risk evaluation, and risk control measures.
• This course also explains the link between ISO 14971 and EU MDR/IVDR expectations for risk management, with examples of how these principles apply in real-world situations.

ISO 14971 Risk Management compliance topics discussed in this course include:

• The scope and purpose of ISO 14971 (Application of Risk Management across the product life cycle of a medical device)

• Definitions of risk, hazard, and harm in a medical device manufacturing context

• The risk management process and life cycle

• Risk analysis and risk evaluation techniques

• Risk control measures and benefit-risk analysis

• What needs to be included in your Risk Management File

• Personnel requirements for risk management activities

• Safety monitoring/post-market release surveillance

• Regional regulatory guidance for implementation of ISO 14971 principles and risk control measures

• ISO 14971 alignment with EU MDR & EU IVDR expectations, FDA regulations, and others

ISO 14971 Compliance Training – Course Format:

• Online, self-paced ISO 14971 compliance eLearning (Allow 2 to 3 hours)

• Includes Quick Quizzes and an online Final Assessment to attain an ISO 14971 Training Certificate of Completion

This course is part of the online GMP/GxP and Medical Device elearning training library.

It complements other modules such as EU MDR & EU IVDR, MDSAP, ISO 13485 QMS for Medical Devices, ISO 22442-2 Medical Devices using Animal Tissues & Derivatives, and others.

Order this Certificate training course now, check your emails for your login information, and start learning today! These courses help you understand what’s required to ensure your medical device risk management processes meet ISO 14971 standards & other relevant requirements.

ISO 14971 Compliance Training by PharmOut

Global Audience & Regulatory Examples

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)

Prepare for your ISO 14971:2019 Compliance Audit

• 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.
• 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.

Who should complete this eLearning course on ISO 14971 compliance? 

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

It will generally be suitable for the following industry personnel roles and other industry stakeholders:

• Medical device designers & medical device production engineers
• Production Managers and Operations personnel
• Quality Testing personnel or third-party auditors
• Auditors and GMP Compliance Inspectors
• Quality Managers & Quality Associates
• Owners/Senior Management
• Medical Device Service Providers
• Medical Device Software Companies (Software support personnel/contractors)
• Equipment Service Contractors
• Designers, repair/service providers, distributors
• Post-Marketing Surveillance Personnel or contractors
• Packaging and Labelling Operators and Logistics Managers
• QMS documentation specialists
• Risk Assessors and Quality Managers
• Site Inspectors – Auditors/Regulatory Authorities

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Medical device regulations and guidance

Utilising a ‘blended’ training approach to ensure compliance with ISO 14971 standards

Online ISO compliance training is best combined with adequate onsite training and Supervision, and product-specific training

• Regulatory compliance courses are not intended to replace onsite Supervision and product-specific training but are complimentary to enhance compliance knowledge
• Regulatory training reinforces a compliance culture and reminds employees of essential QMS requirements and recordkeeping requirements
• Online compliance training also helps personnel prepare for ISO 14971 compliance Audits
• 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

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 Training – Regulatory compliance guidance training course.

Other Medical Device Manufacturing resources that might be applicable: EU MDR & EU IVDR training, MDSAP training, ISO 22442-2 Medical Devices using Animal Tissues & Derivatives, and others.

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.

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

 

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 Principles & Standards

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)/production controls
• ISO risk-management principles & globally respected standards should be incorporated into management policies, processes, work instructions, procedures, and other quality control measures and quality checks for medical device products
• Regulatory Authorities such as the US FDA, the EU EMA, the Australia TGA and others often align their regulatory requirements for medical devices with this ISO 14971 standard.

Do Regulatory Authorities (FDA, TGA, EMA, etc.) refer to the ISO 14971 standard?

Yes, many Regulatory Authorities refer to the ISO 14971 standard in their regulations and during regulatory compliance audits/site inspections. Examples: the European Medicines Agency (EMA) and European Union (EU) regulatory frameworks for medical devices acknowledge and reference ISO 14971 as a key standard for risk management. The EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) recognize ISO 14971 as a harmonized standard, meaning that compliance with the standard provides a presumption of conformity with the relevant regulatory requirements. The United States Food & Drug Administration (US FDA) has also aligned their medical device regulations with the ISO 14971 standard, which you will learn more about by completing this course. 

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.

Certification & Compliance

Upon successful completion of the final assessment, participants will receive a Certificate of Completion, which meets GMP training requirements for personnel files and regulatory audits.

How to Enroll

1. Purchase the course online and receive immediate access.
2. All prices are in US Dollars.
3. Check your email for login details after completing your order (search all folders for ‘onlinegmptraining.com’ or ‘pharmout.net’ and add these to your safe senders list).
4. You can purchase a single course or just a few of the courses you need for just-in-time learning.
5. Note: one learner, one licence (one Training Certificate for each course taken)
6. The learner will have 12 months’ access to the course and a downloadable GMP certificate of completion.
7. Optional: Bundle this training with other GMP courses for additional learning.

Start Your Training Today!

Ensure compliance with the ISO 14971:2019 standard and improve your medical device QMS knowledge.  Enroll now and gain your ISO 14971 Training Certificate to support regulatory and industry requirements. Start your online GMP training today! Be sure to read the FAQs so you know what to expect.

Bundles (Training Packages) & Enrollment Options

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

• Get a training course discount using the Bundles Option
• 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.
• Note: one learner, one cGMP course completion Certificate per course purchase.

Bundled training options let you ‘mix and match’ standard GMP & Medical Device regulatory 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.

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Medical Device Industry Resources

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

ISO 13485 QMS regulatory guidance training course.

Recalls preparation training (certificate course)

CAPA training presentation (live-streamed)

Deviations and Non-Conformances (Management) in cGMP environments

Complaints Handling and Recalls (available now)

Back to the online GMP training store.

FDA CFRs for Medical Devices

Are your SOPs for deviation management out of date?

• Get help from PharmOut’s expert consultants in Medical Device Regulatory Affairs and Production upscaling
• Technical writers for SOPs are also available as PQS/QMS consultants/writers.