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
The Ultimate SaMD Development Plan
Easy Ways to Meet FDA Regulatory Requirements with Your Software Development Plan
Read more
8 Regulatory Strategy Guidelines for Your Medical Device
Learn how your company can form a Regulatory Strategy in 8 easy steps.
Read more
What are CAPAs?
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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
Using Agile in SaMD Development Under IEC 62304
Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
Read more
What is FDA's 21 CFR Part 820?
Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
Read more
Quick Guide to a Successful Clinical Development Program
Unpacking the 4 stages of a Clinical Development Program.
Read more