MIX has teamed up with Axis Research & Technologies
to add value to your MedTech journey
Those in the health sciences are uniquely involved in many aspects of medical device development, from the inception of the idea to its delivery in the marketplace. There is often a “black box” towards the end of this process where a device submission goes into the FDA and you hope an approval or clearance letter comes out the other side. Understanding the mechanisms of the FDA regulatory system governing the marketing and clinical use of medical devices in the United States can be enormously helpful not just at these later stages, but even during the research and development of a new device! Being prepared regarding regulatory pathways and medical device classification will save huge amounts of time, money, and effort.
It is our goal to arm you with the FDA training you need to guide your device through the certification process and have a deep understanding of how the regulatory process is involved in every phase of medical device development.
Online Course
14 weeks of FDA Training
40+ Hours Of Learning Material
$2700/person
The main focus of these courses will be on the regulatory pathways for medical devices only and will not focus on other types of therapies.
You can expect up to 40 hours of material related to FDA submissions and guidance around handling your product with the FDA. This is about the equivalent to one college level course worth of material. This material can be saved and referenced at at a later date as you navigate your product journey with the FDA.
Online Course
14 weeks of FDA Training
40+ Hours of Learning Material
Frequently Asked Questions
The main focus of these courses will be on the regulatory pathways for medical devices only and will not focus on other types of therapies.
You can expect up to 40 hours of material related to FDA submissions and guidance around handling your product with the FDA. This is about the equivalent to one college level course worth of material. This material can be saved and referenced at at a later date as you navigate your product journey with the FDA.