Sponsored Webcast: Mastering your 510(k) Submission Process (June 2024) (On-demand webcast)
Bringing a Class II medical device to the American market? You’ll need to go through the 510(k) process, your gateway to US Food and Drug Administration (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 & Deadlines
Learning Objectives
- Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance
- Learn the most common mistakes the FDA sees in applications, and how to avoid them
- Unpick the key ingredients of a 510(k) submission, from predicate devices and substantial equivalence to typical timelines
Who Should Attend?
- Quality assurance
- Quality managers
- Regulatory managers
- Quality directors
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.
Speakers
Sumatha Kondabolu
Senior Quality Specialist, Qualio
Sumatha has 19 years of regulatory and quality experience across the medical device and pharmaceutical sectors. She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU's MDR, IVDD and IVDR. She holds a 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.
Jeff Flint
Director of Innovation, Cannon Quality Group
Jeff Flint joined Cannon Quality Group as the Regional Director of Quality in May 2021 and has since been promoted to Director of Innovation. During his tenure, he has used his biomedical and quality management engineering background to help organizations take the fear out of quality and implement smarter quality management systems that add value to the business.
Jeff has over 15 years of experience leading quality management efforts at medical device companies and earned a Bachelor of Science in Biomedical Engineering from University of Utah and a Masters of Science in Quality Management & Engineering from Southern Polytechnic State University.
