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Mar 16, 2021 • 2 min read
FDA, pma, 510(k), premarket approval, premarket notification

The Difference Between Premarket Notification 510(k) and Premarket Approval

By Leslie Standridge
Feb 04, 2021 • 6 min read
Medical Devices, FDA

How Long Does the FDA Medical Device Approval Process Take?

By Robert Fenton
Dec 10, 2020 • 3 min read
FDA, Audit

5 FDA Audit Preparation Tips for Life Science Startups

By Robert Fenton
Oct 15, 2020 • 3 min read
FDA, eQMS

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

By Robert Fenton
Sep 29, 2020 • 3 min read
Medical Devices, FDA, 510(k)

5 FDA Pre-Submission Tips for Medical Device Manufacturers

By Robert Fenton
Sep 17, 2020 • 4 min read
FDA, eQMS

A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

By Robert Fenton
Sep 01, 2020 • 5 min read
FDA

Review of the Top FDA Software Validation Requirements

By Robert Fenton
Apr 18, 2019 • 5 min read
Medical Devices, FDA, 510(k)

4 Reasons Overhauling FDA 510(k) is a Great Move

By Robert Fenton
Mar 31, 2018 • 1 min read
Pharmacy, FDA

FDA Rolls Out New Drug Research and Development Pilot Program

By Leslie Standridge
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