Managing the medical device pre-submission process with the FDA

Medical Device Presubmission
There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub) program, these pathways are a way of communicating with the regulator to obtain their feedback on particular topics that are germane to both the manufacturer and the regulator.

Mohammad Asad is the Regional Sales Manager – Asia Pacific at PharmaLex, where he draws on his consulting and industry experience in Australia, the US, and Singapore and on his engineering analytical background to help start-ups and large companies alike bring new and novel technologies to market.

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