Managing The Medical Device Pre-Submission Process With The FDA

Companies seeking FDA approval for medical devices must navigate the distinct intricacies of the US Food and Drug Administration's (FDA) pre-submission process. Referred to as the Q-submission (Q-sub) program, these pathways facilitate communication between manufacturers and regulators, providing a platform to solicit feedback on pertinent topics crucial for both parties.
Speaker Bio: 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.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.