ISO 13485:2016 - Quality Management System for Medical Devices

The international QMS standard for medical device organisations. Covers scope, documentation, management responsibility, resources, product realisation, and measurement & improvement — clause by clause.

Modules

20 modules

Category

Quality Management

Pass mark

80%

Certificate

Free, instant

Audience

Quality, regulatory and manufacturing professionals at medical device manufacturers, suppliers and distributors.

• Understand introduction to ISO 13485
• Understand quality Management System (Clause 4)
• Understand management Responsibility (Clause 5)
• Understand resource Management (Clause 6)
• Understand product Realisation (Clause 7)
• Understand measurement, Analysis and Improvement (Clause 8)
• Understand design and Development Controls in Depth (Clause 7.3)
• Understand purchasing and Supplier Control (Clause 7.4)

• Build a compliant QMS

  Translate ISO requirements into practical procedures, records and controls for your organisation.

• Stay audit-ready

  Understand the exact clauses and expectations auditors and regulators check during inspections.

• Boost your career

  A recognised certificate of completion that you can add to your CV and LinkedIn profile.

• Plain-language modules

  Complex requirements broken into bite-sized, easy-to-remember lessons with examples.

• Free assessment & certificate

  Take the timed exam and earn a personalised, verifiable certificate at no cost.

• Quality, regulatory and manufacturing professionals at medical device manufacturers, suppliers and distributors

• 20 plain-language modules

  Bite-sized lessons with examples, memory aids and key terms.

• Timed assessment

  Multiple-choice exam with 80% pass mark. Retake anytime.

• Verifiable certificate

  Personalised PDF with a unique verification code — shareable on LinkedIn.

• Downloadable resources

  Reference material and attachments available inside modules.

• Lifetime access

  Learn at your own pace — revisit modules whenever you need to refresh.

• Aligned to standards

  Content mapped to internationally recognised medical device standards and regulations.

More questions? Visit the full FAQ.