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Contents In this issue


27 Quality excellence for medical devices CAQ Factory Systems


28 Affirmative action It’s finally here: the FDA’s action plan for regulating medical devices employing AI/ML. Monica Karpinski investigates the key legal, practical and ethical challenges the FDA needs to address, asking what the eventual regulations may look like and how manufacturers can use them to improve the way they work with AI devices.


10 News & numbers


The headlines and vital statistics impacting the market.


Events


13 Go live – with a digital twist Before the pandemic, the medical device industry’s calendar revolved around physical events, where companies exchanged ideas, discussed trends and built relationships. Former Medical Device Developments editor Elly Earls finds out how manufacturers and events organisers have fared with virtual replacements, and what we can expect from post- pandemic gatherings.


19 Opportunities and challenges ahead for medical innovation AMI


Regulatory 20 A seismic shift


After years of fevered speculation, and maybe even a few weeks of planning, OEMs awoke on 26 May 2021 to find that the EU’s new Medical Device Regulation had become legally binding. Gabriel Adusei, associate director at


Medical Device Developments / www.nsmedicaldevices.com


Guidehouse Europe, explains how companies and regulators are adapting to the shifting environment.


25 Risk-based CRO management made easy


Lumis Life Science Consulting


37 28


32 Complete assurance of biocompatibility Toxikon


34 Build confidence through testing WuXi AppTec Medical Device Testing


Contract manufacturing 37 Make it wearable


Whether the technology monitors, manages or stimulates, someone’s probably trying to make it into a wearable – and the market is booming in line with the rise in telemedicine. Abi Millar asks Neil Harris, general manager of Abbott’s diabetes care business in the UK and Ireland, and Bernard Ross, CEO and founder of Sky Medical Technology, how breakthrough devices split the difference between patient and consumer.


43 Evolution of single-use systems for bioprocessing Qosina


44 The perfect mould is a work of art Tegra Medical/Stamm


47 Prove your metal Increasingly, the medical device industry is turning to metal injection moulding to manufacture small complex components. If anyone happened to miss that, the past 18 months have revealed just how important the technology has become. Donald Heaney, editor of the


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