Proxima Clinical Research
Dedicated Clinical Research Organization (CRO) to the New Class of Rising Stars in Drugs, Devices, Diagnostics and Digital Health
The 3 Types of 510(k) Submissions
The Pre-Submission Process
What is Expanded Access?
Dr. Upendra Marathi | Proxima Testimonial
What Is Part 11 Compliance?
What Is An Investigational Device Exemption (IDE)?
Dr. Chester Koh | Proxima Testimonial
Significant Risk vs. Non-Significant Risk In Device Clinical Trials
Paper Based vs. Electronic QMS
What Is A Notified Body?
ABB Robotics | Proxima Testimonial
The Difference Between FDA Registered, Cleared, Granted, Authorized and Approved
The Relationship Between Clinical Trials and Regulatory Affairs
Types of Drug & Biologic Submissions
Can You Use Your Manufacturer's QMS?
FDA Registration - What it Means & What It Doesn't
Examples of SaMD Products
When Should You Start A QMS? | Proxima CRO
Applying For a Product Development CPRIT Grant | Proxima CRO
Advancing Cancer Research with CPRIT's 3 Programs | Proxima CRO
What is a Wellness Device?
Design Controls | Proxima CRO
What Is Substantial Equivalence? | Proxima CRO
Classifying Medical Device Trials | Proxima CRO
BDD vs. STeP | Proxima CRO
Types of Medical Device Trials | Proxima CRO
What Is The Special 510(k)? | Proxima CRO