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Design History File (DHF) deficiencies remain one of the most common causes of FDA Form 483 observations for IVD and medical device manufacturers. This article highlights seven critical DHF gaps frequently identified during FDA inspections, explains why they occur, and outlines practical steps to strengthen traceability, design controls, and inspection readiness before regulatory issues arise.

Entering the U.S. device market requires more than registration. Learn who qualifies as a U.S. Agent under 21 CFR 807.40 and avoid compliance pitfalls

ICH E6(R3) is redefining Clinical Quality Assurance globally. Sponsors must now embed Quality by Design, RBQM, continuous inspection readiness, and stronger vendor oversight across all trials. Read our latest article on what this means for clinical, IVD, and CDx programs.

What will clinical research look like in the next decade? From AI-driven evidence and digital twins to global data-sharing challenges and evolving regulations, the future remains uncertain. Using scenario planning, we explore four plausible futures for clinical trials and examine how sponsors, CROs, and innovators can build the capabilities needed to succeed in any of them.

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FDA Agentic AI - Implications for IVD/CDx Programs of Regulating Wellness and Medical Wearables in an Age of Blurring Boundaries

Regulating Wellness and Medical Wearables in an Age of Blurring Boundaries

How U.S. and EU Decisions Are Reshaping Your Market Strategy by David Petrich and Pieter Bogaert If you're developing in vitro diagnostics (IVDs) for global markets, you just experienced one of the most volatile regulatory years in a decade. In the U.S., a federal court overturned the FDA's proposed oversight of Lab-Developed Tests (LDTs). In Europe, regulators moved in the opposite direction, tightening requirements for In-House Devices (IHDs). For startups, manufacturers, a

Preparing for the New FDA Quality Management Standards The U.S. FDA has taken another step towards global harmonization for medical device regulation. February 2026 marks the official transition to the new Quality Management Systems Regulation (QMSR). This regulation aligns with ISO 13485:2016, which serves as the foundation for regulatory bodies in the EU, Canada, Australia, Japan, Korea, China, and other major regional markets. For diagnostic firms, early-stage startups, an

Meningitis and encephalitis are severe infections of the brain and its protective layers. These infections lead to hundreds of thousands of deaths annually. A far greater number of survivors suffer from devastating, long-term neurological disabilities such as hearing loss, seizures, cognitive deficits, and developmental delay. The people impacted are primarily children, the elderly, and other vulnerable populations in low-income communities. (Meningitis cases primarily happ

The death of actor Chadwick Boseman from colon cancer in 2020 brought widespread attention to the alarming rise of this disease among people under age 50. Digestive health–related conditions now represent one of the fastest-growing chronic health burdens, outpacing many other non-communicable diseases in prevalence. Digestive disorders account for roughly one in every three US medical insurance claims for chronic disease. Beyond colon cancer, conditions such as GERD (gastro

This summer at the 2025 World Expo in Osaka, Japan, a pavilion titled “The Science of the Future” demonstrated tissue of a beating human heart created from skin cells. This was an application of induced pluripotent stem cells (also known as iPSCs). iPSCs are a technology at the heart of the revolution in biology that will transform medicine and scientific research in the coming decades. This year’s expo, featuring exhibits from over 160 countries, is part of a tradition that

Simple frameworks can make a big difference. ISO 9001 Quality Management System standard is a perfect example of this, creating a foundation for multiple industries to deliver consistent, safe, and effective products and services that meet customer and regulatory expectations. Over 2 million companies and organizations, representing over 183 countries internationally, are ISO 9001 certified. They run the gamut from hospitals to factory floors to service fields like education

On March 31 of this year, a federal district court struck down the FDA’s final rule that would have brought Laboratory Developed Tests (LDTs) under FDA regulation as medical devices. The court ruled that the FDA had exceeded its authority, concluding that the LDTs are “professional medical services,” not devices as defined under the Federal Food, Drug, and Cosmetic (FD&C) Act. The new FDA leadership under the Trump Administration has declined to appeal the ruling. This effect

In the hit television series “Homeland”, a fictional vice president is assassinated by terrorists who remotely hack his pacemaker, triggering a fatal heart attack. This Hollywood plot was inspired by the real-life actions of Vice President Dick Cheney after the September 11 attacks. In an era when Al Qaeda dominated the global agenda, Cheney had his cardiologist disable the wireless function in his heart defibrillator. University researchers in 2008 proved this was a credible

The history of medicine is rooted in the intercultural exchange of products and ideas. For millennia, the Silk Road was a vast trading route linking the civilizations of China, India, the Middle East and Europe . Herbs, powders, and medical texts were transported and synthesized across far-flung regions of the known world. ​ Celebrating Clinical Trials Day in 2025, the past is prologue. This is an era when global integration once again plays a vital role in advancing human h

In part 1 of our series on consumer diagnostics, we reviewed the secular trends driving growth in this sector of IVD product diagnostics and clinical trials in the coming decade. This second part of our series focuses on key considerations for trial management and regulatory affairs. In a Boston courtroom last month, the former CEO and two high-ranking executives of the IVD firm Magellan Diagnostics pleaded guilty to criminal charges with the possibility of up to three year

This is Part 1 in a series on the growing opportunity for product development and clinical trials in consumer diagnostics. In 2007, the British Medical Institute surveyed over 10,000 scientists with a question: What medical breakthrough had the greatest impact on extending human lifespans during the past 200 years? The answer was surprising. It wasn’t anesthesia, the X-ray, the EKG or antibiotics. In fact, it wasn’t even a medicine or technology specific to doctors and medica

The International Council for Harmonization (ICH) announced the adoption of its E6(R3) guidelines in 2025. These changes reflect the need for modernized guidance on clinical trial conduct. The clinical research space has undergone rapid technological and procedure change in the five years since the COVID-19 pandemic began. ​ The ICH, which serves as a global forum for regulatory authorities and the medical industry, now provides greater clarity for globally harmonized Good Cl

Software and life sciences are converging to accelerate drug and device development. Innovations in machine learning (ML) have transformed early-stage drug discovery during the past five years. Now, breakthroughs such as Generative Artificial Intelligence (Generative AI) offer the potential to reduce costs, delays and risks traditionally associated with clinical trials. It wasn’t always such a hopeful story. For decades the rate of progress in software and the life scie