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ISO Courses

ISO 14155 – Clinical investigation of medical devices for human subjects — Good clinical practice

Training course on ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice. (Published 2026)
5,000.00 LE

ISO 10993-6 – Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Training course on ISO 10993-6: Biological evaluation of medical devices — Part 6: Tests for local effects after implantation. (Published 2026)
5,000.00 LE

ISO 15223-1 – Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Training course on ISO 15223-1: Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. (Published 2021)
5,000.00 LE

ISO 11607-3 – Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly

Training course on ISO 11607-3: Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly. (Published 2026)
5,000.00 LE

ISO 13485 – Medical devices — Quality management systems — Requirements for regulatory purposes

Training course on ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes. (Reviewed 2025)
5,000.00 LE

ISO 10993-1 – Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Training course on ISO 10993-1: Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process. (Published 2025)
5,000.00 LE

ISO 10993-7 – Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Training course on ISO 10993-7: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. (Published 2026)
5,000.00 LE

ISO 20417 – Medical devices — Information to be supplied by the manufacturer

Training course on ISO 20417: Medical devices — Information to be supplied by the manufacturer. (Published 2026)
5,000.00 LE

ISO 10993-3 – Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

Training course on ISO 10993-3: Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity. (Published 2026)
5,000.00 LE

ISO/IEC 29138-1 – Information technology — User interface accessibility — Part 1: User accessibility needs

Training course on ISO/IEC 29138-1: Information technology — User interface accessibility — Part 1: User accessibility needs. (Published 2018)
5,000.00 LE

ISO 11040-8 – Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes

Training course on ISO 11040-8: Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes. (Published 2026)
5,000.00 LE

IEC 62304 – Medical device software — Software life cycle processes

Training course on IEC 62304: Medical device software — Software life cycle processes. (Reviewed 2023)
5,000.00 LE

ISO 10993-17 – Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

Training course on ISO 10993-17: Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents. (Published 2023)
5,000.00 LE

IEC 62366-1 – Medical devices — Part 1: Application of usability engineering to medical devices

Training course on IEC 62366-1: Medical devices — Part 1: Application of usability engineering to medical devices. (Reviewed 2021)
5,000.00 LE

ISO 5833 – Implants for surgery — Acrylic resin cements

Training course on ISO 5833: Implants for surgery — Acrylic resin cements. (Published 2026)
5,000.00 LE

ISO 14971 – Medical devices — Application of risk management to medical devices

Training course on ISO 14971: Medical devices — Application of risk management to medical devices. (Reviewed 2025)
5,000.00 LE

ISO/TS 24971-2 – Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence

Training course on ISO/TS 24971-2: Medical devices — Guidance on the application of ISO 14971 — Part 2: Machine learning in artificial intelligence. (Published 2026)
5,000.00 LE

ISO 14644-5 – Cleanrooms and associated controlled environments — Part 5: Operations

Training course on ISO 14644-5: Cleanrooms and associated controlled environments — Part 5: Operations. (Published 2025)
5,000.00 LE

ISO 11607-1 – Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Training course on ISO 11607-1: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. (Reviewed 2024)
5,000.00 LE

ISO/TR 24971 – Medical devices — Guidance on the application of ISO 14971

Training course on ISO/TR 24971: Medical devices — Guidance on the application of ISO 14971. (Published 2020)
5,000.00 LE

ISO 10993-23 – Biological evaluation of medical devices — Part 23: Tests for irritation

Training course on ISO 10993-23: Biological evaluation of medical devices — Part 23: Tests for irritation. (Reviewed 2026)
5,000.00 LE