MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.
Recently, biocompatibility consultant, MedTech enthusiast and chemist, Marina Daineko, shared a series of LinkedIn posts defining, medical device biocompatibility and the need for a Medical Device biological risk assessment “framework.” Following is a reposting of Marina’s original LinkedIn series.
nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.
Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.
Misconceptions about using Regulatory Information Management (RIM) platforms to manage MedTech regulatory workflows. Here, we Bust 3 Naysayer Myths.
Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.
The common theme illustrated in a recent survey among medical device regulatory professionals is the need for increased resources, expertise, and technology. The data validates industry concerns of increasing workloads and overtime hours, and how many companies are finding it hard to recruit suitable skilled regulatory associates. Medical device company RA/QA teams raise concern about deficient competencies and resource availability with increasing regulatory complexity and changing global requirements.
An analysis from the Life Sciences legal team at Hogan Lovells.
Explore our EU MDR Checklist designed to help you navigate EU MDR compliance. This practical tool guides you through essential steps to adapt your processes and ensure documentation meets regulatory standards. Start your compliance journey with confidence.
As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
