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)....
The integration of Artificial Intelligence in medical devices is revolutionizing healthcare delivery, with the potential to improve patient outcomes, reduce costs, and increase access to care. From diagnostic systems to imaging devices, AI is being used in various...
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...
On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 2 of a series of...