Module 14 2022

22/03/2022

Suggested further reading

● Baumgarten D: Brainstorming techniques to jumpstart device designs (available online, first issued 2013) ● Cambridge Consultants: Good Design Practice for medical devices and equipment 2 (https://www-edc.eng.cam.ac.uk/downloads/gooddesignpractice2.pdf ● Durfee WK, Iaizzo PA: Medical Device Innovation Handbook (available online) ● Busch et al: Optimizing the innovation and development process of medical devices - a study based on angiographic equipment (available online) ● Green Guru: Ultimate guide to design controls for medical device start-ups (2018) https://www.greenlight.guru/blog/design-controls ● Teixiera MB: Design Controls for the Medical Device Industry (2021) ● USFDA: Design Control Guidance for Medical Device Manufacturers (1997 - latest version 2018)

© TOPRA and Dr Helen Erwood ESPL Regulatory Consulting

helen@espl-regulatory.com

The Organisation for Professionals in Regulatory Affairs

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