ISO 13485: Quality Management Systems for Medical Devices

USD $35.00

Course duration: Allow 2 to 4 hours to complete this course.

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ISO 13485: Quality Management Systems for Medical Devices

QMS requirements for Medical Devices

Learn what’s required in terms of QMS documentation including:

  • Medical Device QMS – Quality Policy
  • Quality Objectives
  • Quality Manual
  • Personnel competency assessments and training programs
  • Resource Management
  • Management Reviews
  • Risk Management Strategies
  • Common audit findings relating to Medical Device QMS deficiencies
  • ISO 13485 vs MDSAP

Medical Device regulations: ISO 13485 QMS training

Preparing your team to comply with Quality Management System (QMS) requirements for Medical Devices.

  • This course is suitable for any business that manufactures, services, imports/exports and/or distributes a Medical Device
  • It’s available in an online, self-paced format – once the learner passes the Final Assessment, they will gain a Certificate of Completion for their personnel file (or for your training records)
  • This ISO 13485 QMS compliance training course is suitable for a wide range of personnel, including:
    • Quality Managers & Quality Associates in Medical Device Sectors
    • Personnel and Contractors including Service Providers
    • Engineers and medical device designers
    • Purchasing teams
    • Operations team members through to Quality Managers and Founders/CEOs
    • Medical device software designers and software update support personnel
    • QMS documentation specialists

ISO 13485: QMS standards for Medical Device Manufacturers, Service Providers, & Distributors

Completing this Certificate GMP training course in ISO 13485 QMS for Medical Device companies will help your team learn what’s expected by Regulators in terms of:

  • Quality Management System Documentation
    • QMS documents including procedures/SOPs
    • Management review meeting documentation
    • Personnel Competency Assessments
    • Corrective and preventive actions
    • Auditing schedules and more
  • Quality Risk Management (QRM) principles and risk-based decision making
  • Rules for exceptions to ISO 13485 requirements (documented justifications)
  • Product Risk Classes (Product Risk Classifications)
  • How ISO 13485 compares with MDSAP and other standards such as ISO 9001
  • Importance of  Root cause analysis and CAPA documentation

This online GMP training course will answer common FAQs about ISO 13485 requirements for your Quality Management System (QMS) including documentation, personnel training, self-inspections, audits, management reviews, validation requirements, and quality controls.  

Medical Device Products: Quality Control Requirements

  • What are the regulatory requirements for establishing an effective Quality Management System (QMS)?
  • What procedures and documentation controls are required to ensure compliance with ISO 13485?
  • How are documents controlled to avoid use of obsolete documents?
  • What measures are necessary in terms of ensuring change controls?
  • Which procedures need to be validated?
  • How does ISO 13485 compare to MDSAP requirements?
  • What is the difference between ISO 13485 and ISO 9001?

Learn about ISO 13485:2016 QMS requirements 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 QMS requirements from Regulatory Authorities such as:
  • EU EMA
  • US FDA
  • Australian TGA (UPRTG)

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

This self-paced ISO compliance training course explores ISO 13485 guidance, covering QMS standards for medical device businesses.
Course content is based on publications from ISO, the FDA, TGA, MHRA, and other regulators, and insights from our team of regulatory compliance experts for medical device businesses.
  • It includes information on MDSAP vs ISO 13485 requirements and audit differences.
  • 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 recalls course is suitable for a worldwide audience.


The course includes ISO 13485 guidance (global standards for establishing and maintaining an effective Quality Management System).

It also includes references to QMS guidance specific to the US (FDA QMS guidance in CFR 21 Part 820), Australia (TGA guidance for medical devices and IVDs), and the other regulators listed previously.

This certificate ISO 13485 compliance training course for Medical Devices is ideally suited for:
  • Business Owners and Operations Managers
  • Pharmaceutical Service Providers
  • Medical Device industry personnel
  • Medical device manufacturing personnel
  • Medical device Quality Managers and Quality Assurance teams
  • Design engineers and device maintenance personnel and/or device quality testing managers
  • 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
  • Other personnel working in a GMP/cGMP environment


Earn your GMP training certificate in “ISO 13485” to add to other GMP education topics including deviations management, complaints management, and CAPA!

This newly-released ISO 13485 (Medical Device QMS Guidelines/Medical Device Regulations) training course is ideal to complete along with the Complaints Management course, the Deviations and Non-Conformances management course, and the CAPA systems training course.

GMP industry and ISO 13485 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.

With online training for ISO13485, 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 (such as this Product Recalls 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 SOPs for CAPA?

Note: All course prices are in US dollars.



Bundled training options let you ‘mix and match’ standard 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

Review other top-ranked GMP courses and best-practice GMP training courses.

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: “” and”.

One user/per licence purchase (12 months’ access)

  • This ISO 13485 (regulatory compliance) education course 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.

ISO 13485 QMS Training Course Benefits:

complaints management regulations PIC/S FDA CFRs ISO MHRA EMA

  • The training course will assist personnel to understand Regulatory expectations for quality management systems 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 4 hours to complete this ISO 13485 QMS (Medical Devices) eLearning training course including the online Final Assessment.


Other recommended courses include:

CAPA training presentation (live-streamed)

Deviations and Non-Conformances (Management) in cGMP environments

Complaints Handling and Recalls (available now)

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