EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help? AI-driven tools and automations enhance productivity,…
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.
What are the essentials for compliant claims? How do you support and monitor claims in packaging and promotional content? Creating and following internal procedures is a strong defense.
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.
As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations mean for laboratories developing and selling LDTs.
MedTech organizations need to focus on the human factor of change and achieve top-down alignment, buy-in, accountability, and clear communication along the way.
Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.
