White Papers
Managing Bias in AI
If we can’t “engineer out” bias from the design and development of AI software applications, and if we can’t remove human bias from the use or application of the software, then what tools do we have to manage bias in and around AI? How do the FDA's Good Machine...
Breakthrough Device Designation: I've Received the Designation, Now What?
Being in uncharted territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high...
The Evolution of a QMS
It is so important to develop your Quality Management System (QMS) around: your medical products, your organizational structure, your company’s maturity, and your global strategy. Both FDA’s Quality System regulation and ISO 13485:2016 give you this...
The Future of Clinical Trials Series: Remote Monitoring of Patient Health and Compliance
Revolutionize the future of clinical trials with remote patients monitoring! Our white paper explores how RPM can help ensure the reliability, security, and integrity of clinical data used in decentralized clinical trials. With RPM, sponsors, investigators, and...
Finding a Balance: The Delicate Trust Relationship Between AI in Medical Devices and Patients
With the rise of AI-enabled medical devices, the public has become increasingly concerned about data privacy and security. However, having a wide range of data is essential when training AI algorithms. Inputs must be varied to ensure that the algorithm is as robust as...
Breakthrough Devices Program: What Is It and How Do I Get It?
Doesn’t every manufacturer dream of new product development occurring in concert with FDA’s real time accelerated submission process? Well, here’s your chance! This white paper is to clear up any confusion regarding navigation of the Breakthrough Devices Program. It...