Contract manufacturing


Class III devices Manufacturing


Class III contract manufacturing is soaring. Encompassing the most complex medical devices – for instance, pacemakers and deep-brain stimulators – research suggests they will enjoy the highest CAGR of any class through the end of the decade. But beyond the potential advantages to contract manufacturing organisations (CMOs), and indeed the patients who rely on these machines, what must companies do to ensure they can build Class III devices effectively? Phoebe Galbraith investigates, with help from a range of experts.


edical life would be inconceivable without Class III technology. Representing high-risk medical devices – considered essential to support or sustain life – examples include pacemakers and defibrillators, which represent 10% of medical devices regulated by the FDA. Due to the level of complexity and the critical nature of these devices, meanwhile, it is no wonder that they undergo the strictest scrutiny for market approval. Compliance and


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regulatory adherence are paramount, as Class III devices are subject to stringent requirements from bodies such as the FDA, requiring rigorous quality control through documentation, and regular audits from outside experts.


Lawmakers, for their part, are transforming the Class III sector too. Since the adoption of the European Medical Device Regulation 2017/745 (EU MDR), the medical device field has seen significant


Medical Device Developments / www.nsmedicaldevices.com


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AI generated/Shutterstock.com


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