5 Ways to Stay Compliant with 21 CFR Part 11
Learn how to stay compliant with FDA's Part 11 in the age of automation!
Read more
How to Create Successful SOPs for your Medical Device
Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
Read more
What are Standard Operating Procedures (SOPs)?
Defining SOP’s as they pertain to your Medical Device.
Read more
A Simple Guide to 510(k) Applications for Medical Devices
Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
Read more
6 Preliminary Questions Around FDA’s RTA Policy for 510(k)
Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions
Read more
8 Guidelines for your Medical Device Regulatory Strategy
Learn how your company can form a Regulatory Strategy in 8 easy steps.
Read more
FDA’s Emergency Use Authorization (EUA) to Combat the Coronavirus
How Emergency Use Authorization is shaping the regulatory landscape of Healthcare during the COVID-19 pandemic.
Read more
How to Utilize CAPA in 10 Easy Steps
Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
Read more
A Quick & Easy Guide to FDA Pre-Submissions
A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
Read more
20 New FDA Biological Approvals in 2019
A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.
Read more