Alzheimer’s Disease Clinical Trials | 1MED MedTech Innovation
Advancing Alzheimer’s Care Through Clinical Trials: How 1MED Supports Innovation in Medical Devices Discover how 1MED advances Alzheimer’s care through clinical trials of innovative medical devices for diagnosis, sleep safety, and daily life support. Alzheimer’s disease is one of the most pressing health challenges of our time. As a progressive neurodegenerative condition, it impacts memory, […]
Enhancing Ileo-colo-rectal Mesalamine Levels for Better Ulcerative Colitis Care
Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease (IBD) that primarily affects the colon and rectum. Characterized by symptoms such as abdominal pain, diarrhea, and rectal bleeding, UC presents significant challenges for both patients and healthcare providers. Its global incidence is rising steadily, particularly in newly industrialized countries, pointing to a combination of […]
Advancing Innovation in Cardiopathology Research: 1MED’s Role in the Quantum Perfusion Cannula Study
Cardiovascular disease remains the leading cause of death globally — and the demand for safe, effective, and innovative technologies has never been greater. At 1MED, we are proud to support transformative clinical research in cardiology, from high-risk interventions to cutting-edge mechanical circulatory support systems. One such initiative is our full clinical and regulatory oversight for […]
Smart Solutions for Clinical Data Collection – Do I really need a Trial?
Introduction The introduction of Regulation (EU) 2017/745 (MDR) has brought a seismic shift in how medical device manufacturers must approach clinical evidence. MDR places the burden on manufacturers to provide an adequate level of clinical evidence proportionate to the device’s risk profile. While traditional clinical trials remain the gold standard, the MDR also recognizes alternative […]
Navigating Swiss Regulations: What Swissdamed Means for Economic Operators
SWISSMEDIC, the Swiss Agency responsible for the authorization and oversight of medicinal products and medical devices, recently announced the launch of “Swissdamed,” a new platform for medical devices, beginning in late August 6, 2024. The rollout is occurring in phases, with the initial release of the “Actors” module, which allows economic operators to register through […]
Pediatric Research for a Healthier Start: Spotlight on Infantile Colic and Clinical Trials
World Health Day Spotlight: Pioneering Pediatric Research for a Healthier Start and Advancing Pediatric Health Through Clinical Trials on Infantile Colic in Newborns Every year on April 7th, World Health Day draws global attention to pressing health issues and celebrates milestones in healthcare and honor global efforts to improve healthcare access and outcomes. This year, […]
Italian CRO, LB Research, Joins the 1MED Group
1MED today announces that LB Research is now part of the 1MED Group. Established in 2007 and based in Como, Italy, LB Research is a full-service contract research organisation providing clinical trial management across all clinical product life cycle phases. LB Research operates with a highly skilled team of 24 professionals and maintains a diverse […]
TOP 5 most urgent tasks for MDR compliance before 2024
Following the success of the 1TALK event on November 30th, 1MED team is organizing in-depth webinars on the main regulatory and clinical issues necessary for the transition from MDD to MDR. The aim is to provide companies with clear information to create the necessary awareness to facilitate the adoption of MDR and offer information on […]
An insight on the improvements in the medical device industry
From today we start the distribution of our video in the US on national, regional and public tv networks. Enjoy the preview! https://player.vimeo.com/video/701949751
Discovery Pack – MDD to MDR
MDR Grace Period ends May 26th 2024. As this date approaches, manufacturers are requested to focus even more closely on how to plan transition for the legacy devices in their portfolio. For MDD to MDR transitions manufacturers are asking themselves: “Are we prepared for re-certification according to MDR?” “Do we have sufficient clinical data for […]