Module 14: Design, Development and Certification of Medical Devices - 7FHH1152

Design, Development and Certification of Medical Devices

Next course: January/February 2022

Enables students to demonstrate an understanding of the development, manufacturing and GxP (good practice) requirements for medical device product development, including the concept of risk management and the ways in which it is managed from the design stage onwards.

Overview

This module covers control of design and development; input and output requirements and the required documentation using example devices. It also looks at the impact of materials choice, design, verification, validation and certification of medical devices as well as the applicable legislation, regulatory standards, guidance and other documents (including GxP).

Other topics include packaging and labelling (including unique device identification); biocompatibility and toxicology, risk management (including ISO 14971 and feedback of PMS data); as well as additive manufacturing and sterilisation.

Great course with excellent professionals as speakers."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Critically evaluate the design of a device including the materials it is made from
• Demonstrate critical understanding of the safety and performance of devices using applicable product standards for the EU and other global markets /li>
• Critically evaluate the principles and practice of risk management as set out in ISO 14971 to a level where they can apply it to a complex medical device
• Create and appraise the documents required to apply for certification of medical devices for the EU and other global markets.

Skills and attributes

Successful students will typically:

• Give appropriate advice to the medical device team on key regulatory issues affecting design, development and manufacturing of devices
• Produce the necessary technical documentation within project timeframes
• Critically appraise and evaluate communications from competent authorities, notified bodies and research publications covering design, development and certification of medical devices globally

Developing expertise in all areas of medical devices? Consider:

• Module 15: Clinical Evaluation of Medical Devices
• Module 16: Post-Market Surveillance and Vigilance for Medical Devices
• Module 17: Regulatory Strategy in the Post Market Phase
• Module 21: US Regulation of Medical Devices

Expanding your options? Consider:

• Module 12: Data Management and Digitalisation in Regulatory Affairs
• Module 18: Drug-device Combinations and Other Technologies
• Module 22: Regulatory Requirements for Cell, Tissue and Gene Therapies

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.