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Anti-Snore Mouthguard
As an FDA Class II medical device, this injection-moulded mandibular advancement device was subject to strict design & safety controls. This boil & bite device can be purchased off-the-shelf to reduce snoring by advancing the lower jaw forwards.
Using the FDA 510 (k) approval pathway, we selected a suitable predicate and used this as a basis for creating the design & testing strategy.
My role was to design the complex overmoulded components (ISO 10993) while working alongside a regulatory consultant to implement the quality system.
*The images seen here are of an identical product for the EU market as the US product images have not yet been released publicly
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