Lori A Carr MDR (the European Union [EU] Medical Device Regulation), MDSAP (the Medical Device Single Audit Program), and FDA Inspections demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market access.
In a move meant to bolster the adoption of Artificial Intelligence (AI)-enabled digital health products, the US Food and Drug Administration (FDA) in January 2026 updated two guidance documents to ease its oversight of general wellness devices and Clinical Decision Support (CDS) software.
The International Medical Device Regulators Forum (IMDRF) has outlined its vision for the next five (5) years, which includes further engagement with the medtech industry to ensure promising products reach patients quickly. The group also plans to reform its governance structure as it continues to grow its membership to ensure long-term sustainability.
A study in Nature Communications found that long COVID follows eight (8) symptom trajectories, varying in severity and duration. Researchers tracked 3,700 adults and found 10% developed long COVID, with 81% of those still having symptoms a year later. “The variability we identified will enable future studies to evaluate risk factors and biomarkers that could explain why patients vary in time of recovery, and help identify potential therapeutic targets,” said lead researcher Tanayott Thaweethai.
Personalized immunotherapy enters human trials: A personalized immunotherapy developed at Colorado State University (CSU) that extended the life of a dog with cancer is set to begin human trials. The immunotherapy uses a patient’s own inactivated tumor cells to train the immune system to recognize and attack the cancer, and a clinical trial at City of Hope in California will involve patients with recurrent ovarian cancer.
A Management Review is meant to be one of the most strategic tools in a management system. It brings leaders together to reflect on performance, understand the state of the system, and make changes to benefit the system. Yet, too often, these meetings become predictable. Data is at times “massaged” to give leadership a warm and fuzzy feeling.
The European Commission (EC) has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission in December 2025 to advance the biotechnology sector, enhance access to cardiovascular treatments, and streamline medical device regulations.
Every quality professional knows the feeling — that sudden jolt of anxiety when an audit notification hits the inbox. Despite robust systems, documented Standard Operating Procedures (SOPs), and periodic training, many organizations still scramble when Auditors come calling. The truth is simple: audit panic is a symptom, not a cause. It signals a gap between the Quality Management System (QMS) and what is lived daily.
Over the past year, industry has been seeing a pattern in several FDA interactions that are worth talking about openly…one professionals opinion…
Cognitive fatigue is being studied more intensively due to its prevalence in conditions such as long COVID, chronic fatigue syndrome, and multiple sclerosis, with researchers developing better biomarkers, behavioral tools and potential treatments. Leading theories suggest that when the brain engages in sustained, effortful thinking such as complex problem-solving or navigating unfamiliar situations, demands on neural circuits may deplete cellular energy or allow metabolic waste products like glutamate to accumulate, triggering fatigue as a protective signal to rest.