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Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

In the rapidly evolving field of healthcare technology, NAMSA provides expert guidance on navigating the complex regulatory landscape for Medical Device Software (MDSW) in Europe. The blog discusses the importance of clinical and performance evaluations according to EU regulations, highlighting the challenges manufacturers face in demonstrating safety and effectiveness. It emphasizes the need for thorough data analysis and risk assessment, particularly in areas like software safety, risk classification, and the lifespan of MDSW. NAMSA’s specialized medical writing teams offer their extensive expertise to assist MDSW manufacturers in achieving compliance and fostering innovation within the digital health space.

Three Essentials for a Good Clinical Study Report

Learn the key elements of a compelling CSR for medical device success with NAMSA’s expert guidance.

Manuscript Publishing Advice: Write for Physicians

This blog delves into how to write medical manuscripts in a way that appeals to physicians and increases the chance of publication.

MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews

On January 27, 2022, MDCG 2022-2: “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” was published. This document provides information for manufacturers, regulators, investigators, sponsors, Notified Bodies and other industry stakeholders concerning the continuous process for IVD performance evaluation.