The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
Read more

4 Ways AAMI TIR45 Proves Beneficial for SaMD Development

Easy Guidance for SaMD Development and Agile Practices
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

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

Top 20 Medical Device Conferences to Attend in 2020

A simple breakdown of 20 conferences you don't want to miss this year.
Read more

What is ISO 13485:2016?

An easily digestible overview of ISO 13485 and how it applies to your medical device company.
Read more

Medical Device Single Audit Program (MDSAP) Explained

A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
Read more

ISO 13485 - Regulatory Requirements on Medical Devices

How embracing regulations can give you a leg up on your competition.
Read more

FDA Pre-Cert 101: Beginner's Guide + Latest Updates

A simple breakdown of the Software Pre-Certification Program and how it affects your company.
Read more

Medical Device Software & SaMDs: A Crash Course

A quick and easy rundown of ISO and IEC standards. 
Read more

Recent Posts

Topics

See all

Subscribe Here