Mastering your 510(k) submission process (On-demand)
This is an on-demand recording from June 2023
Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to FDA clearance. Yet many businesses are getting it wrong: successful applications are falling, and 30% of 2021 applications weren’t even accepted for initial review.
A robust 510(k) plan is crucial for a smooth and speedy route to market. This webinar gives you everything you need to know to become a 510(k) master.
Registration Fees
Free
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Who Should Attend?
Quality assurance Quality managers Regulatory managers Quality Directors
Speakers:
Sumatha Kondabolu
Senior Quality Specialist, Qualio
Sumatha Kondabolu brings more than 19 years of experience in the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations.She has built quality management systems for compliance with the FDA QSR, Canada’s medical revices regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD and IVDR.She holds a bachelor’s of pharmacy, master’s in chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949.
