BSI Launches New CE-Dedicated FastTrack Program
RESTON, VA. and PHILADELPHIA
BSI announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. CE-Dedicated FastTrack offers reviews at an accelerated pace, within 45 working days or less. A key feature of the program is that BSI Product Experts dedicate a period of time to work exclusively with a particular client to complete the review, therefore travelling to the customer site is not required. CE-Dedicated leverages a range of communication technologies, paperless submissions and expertise that can quicken the review process to get new medical devices into the European market providing patients access to new technology.
CE-Dedicated is the fourth in a series of BSI Speed-to-Market Programs designed for Class III medical devices requiring CE marking design dossier reviews. Programs include: CE-90 standard, which completes most reviews within 90 working days from submission; CE-45 FastTrack, expedited reviews within 45 working days; and CE-Onsite FastTrack in which BSI Product Experts conduct reviews at the customer’s premises targeted at 45 working days.
“By utilizing high-tech capabilities, we provide a dynamic and personalized information interchange over geographic distances that streamline the entire review process,” states Ron Rakos, Vascular Team Leader, BSI Healthcare.
CE-Dedicated is not designed for all products, such as ones containing medicines, animal or blood derivatives that require the use of outside agencies and may not be eligible. Although BSI cannot guarantee a positive recommendation, the CE-Dedicated review provides manufacturers the benefit of knowing where they stand sooner in the process and a progress report for briefing upper management. The complexity of the product, timelines and regulatory requirements impact which program is best suited to the client’s needs. BSI works with clients to determine the right fit for each product.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
