Module 20: Regulation of Electrical, Electronic and Software Devices 7FHH1158

Regulation of Electrical, Electronic and Software Devices

Next course: 29 September 2021

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Examines the practical and strategic regulatory issues relating to the development, maintenance and marketing of active devices (which includes electrical, electronic and software), enabling students to explore and critically debate the commercial implications and the impact of the regulations on product stakeholders.

Overview

The regulation and approval of software devices is particularly challenging with limited guidance available and very few experienced professionals, the challenges and hurdles will be explored as well as some potential solutions and areas in which more guidance is needed.

This module covers the legislative requirements for electrical, electronic and software devices as well as the current guidance. Practical considerations for designing, developing and gaining approval for these devices will be discussed.

Speakers were excellent orators with an abundance of hands on practical industry experience."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Demonstrate a systematic knowledge and critical awareness of the theory and practice of active devices regulation
• Be able to determine and justify which classification an active medical device falls into and identify the relevant conformity assessment procedure
• Critically evaluate the regulations and their impact on development, maintenance and marketing of active devices
• Understand the importance and content of key medical electrical equipment and systems safety standards
• Possess a comprehensive understanding of the unique issues relating to active devices and their use.

Skills and attributes

Successful students will typically:

• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations for active devices
• Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to non-specialist and specialist audiences
• Critically appraise and evaluate communications from regulatory bodies and research publications covering active devices.

Building regulatory expertise in evolving medical technologies? Consider:

• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 20: Regulation of Electrical, Electronic and Software Devices
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

Expanding your options? Consider:

• Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products
• Module 14: Design, Development and Certification of Medical Devices
• Module 15: Clinical Evaluation of Medical Devices
• Module 16: Post-Market Surveillance and Vigilance for Medical Devices
• Module 21: US Regulation of Medical Devices

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.