With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous submissions to multiple national regulatory authorities, paving the way for a much anticipated fully digital, single global dossier.
Medical device companies are aiming to optimize their Clinical Evaluation Report (CER) submissions and streamline compliance process. How are RA teams putting together practical strategies for improving efficiency, reducing risk, and staying compliant with MDR regulations?
An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.
If you’re considering a RIM system, it’s critical to determine the right scope, software capabilities, and balance between cost and value. Learn how to evaluate each piece with this RIM buyer’s guide for medtech.
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.
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.
Law firm, Hogan Lovells, analyses the implications of the AI Act for the Medtech sector and highlight a number of key challenges for medical device manufacturers and their partners in aligning conformity routes for their products under the AI Act.
Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
An analysis from the Life Sciences legal team at Hogan Lovells.
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.
