White Papers
Benefits of Decentralized Clinical Trials
Want faster, more diverse subject recruitment for your clinical trial? Or are you interested in running a trial utilizing digital health technologies? If yes, then a Decentralized Clinical Trial (DCT) might be right for you! There are many steps and parts to complete...
Dropping the SBOM: FDA’s Cybersecurity Refuse to Accept Policy
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...
FINAL Guidance Released: Qualification of Medical Device Development Tools
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...
Risk Management Data for a Life-Cycle Approach: IMDRF Adverse Event Codes
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,...
Systems for Patient Engagement in Decentralized Clinical Trials
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...
Top Risks for Large Language Models
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...