Whether you are a start-up company or a well-established business, auditing is not only an integral part of the business process, but also a requirement. Knowing the right timing to implement the quality audit program within the quality system lifecycle and how audits...
Decentralized clinical trials (DCTs) are becoming more and more popular as a means of improving patient access and participation, reducing costs, and increasing efficiency. However, DCTs also present unique challenges in terms of data collection and management,...
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...
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...
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...
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...
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...
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...
Determining the right size of a Quality Management System (QMS) can make some feel like they are on a roller coaster ride and not know how to navigate the numerous drops and turns. Although developing a QMS is a requirement, it does not need to be overwhelming....
Decentralized Clinical Trials (DCT) are here to stay! In 2007, the FDA and Duke University partnered to develop and drive the adoption of practices for increased quality and efficiency of clinical trials and formed Clinical Trials Transformation Initiative (CTTI)....