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
Free
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 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.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org