Discover the future of medical device cybersecurity in this riveting White Paper! Executive Order 14028 has ignited a shift in the industry, with NTIA unveiling the essential elements of a groundbreaking Software Bill of Materials (SBOM). Brace yourself for a...
Are you equipped with a cutting-edge tool for advancing medical device development? Whether you’re currently utilizing such a tool or crafting one, the recently unveiled definitive version of the “Qualification of Medical Device Development Tools” guidance holds the...
Unleash the Future of Medical Device Coding: Mastering IMDRF Adverse Event Codes! Step into a cutting-edge world of medical device coding, where the power of IMDRF Adverse Event codes revolutionizes patient safety. Join the FDA and EU as they embrace this approach,...
Discover new digital systems for patient engagement in decentralized clinical trials (DCTs)! Explore how digital systems are designed to empower patients and ensure their active involvement from: Electronic patient recruitment and retention; Digital data sharing and...
Transforming the landscape of artificial intelligence, Large Language Models (LLMs) such as ChatGPT and Bard (a conversational generative artificial intelligence chatbot developed by Google) have taken center stage, captivating many industries with their immense...
You NEED the FDA eSTAR Quick Guide! Who remembers when Microsoft Office first came out? Everyone was learning and an Excel or Word laminated cheat sheet could be bought at the grocery store to help with the learning curve. This eSTAR White Paper has a similar intent,...
Are you in the early stages of design development of a product? Or do you need help remediating your Design History File? This White Paper will provide guidance on the global requirements of design control and the documented evidence needed to meet global regulatory...
With the increased popularity of the decentralized and hybrid models of clinical trials come unique challenges, especially regarding investigational device management and training execution. In this new MEDIcept White Paper, the importance of supply and training...
How do you predict what cybersecurity requirements will be at the end of your product development lifecycle? Technology evolves rapidly, and with it, technological capabilities of threat actors seeking to profit or cause harm from malicious activities targeting...
Are you in early stage development of a device or device-led combination product? The FDA has rolled out a number of initiatives over the past several years to facilitate more timely access for patients to innovative medical devices and technologies. One such...