Medical Device Fundamentals

An introductory course covering what a medical device is, how it is classified in the EU, US and India, the full product life-cycle, the roles and responsibilities of every player in the industry, and the terminology used across standards and regulations.

Modules

15 modules

Category

Fundamentals

Pass mark

80%

Certificate

Free, instant

Audience

New entrants and cross-functional teams (R&D, quality, regulatory, clinical, marketing, sales, supply chain) who need a common foundation in medical device terminology, classification, life-cycle and roles.

• Understand introduction to Medical Devices
• Understand brief History of Medical Device Regulation
• Understand medical Device Terminology
• Understand device Classification: European Union (MDR)
• Understand device Classification: United States FDA
• Understand device Classification: India (MDR 2017)
• Understand global Harmonisation: GHTF, IMDRF, MDSAP
• Understand product Life-Cycle: Overview

• Solid foundation

  Grasp the core concepts, vocabulary and frameworks used across the medical device industry.

• 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.

• New entrants and cross-functional teams (R&D, quality, regulatory, clinical, marketing, sales, supply chain) who need a common foundation in medical device terminology, classification, life-cycle and roles

• 15 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.