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.
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.
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.
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.
Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).
This European Medicines Agency (EMA) Question & Answer document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices.
“With this strategic alliance we are strengthening our worldwide presence and can serve the needs of our customers anywhere. With teams of seasoned consultants both MEDIcept and Pure Global offer deep expertise across a wide range of compliance needs.”
Regulatory excellence is now considered a pathway to innovation and sustained business growth, making it a fundamental component of success in the medical devices industry. MedTech manufacturers are fostering a culture of regulatory excellence to enhance compliance with regulatory requirements and ensure product safety, efficacy, and quality in the global marketplace.
Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.
