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A Product Development Plan For My Laboratory Developed Test

Discover key strategies for LDTs facing FDA regulation changes in our latest blog on product development planning.

Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA’s expert insights and auditor feedback for medical device manufacturers.

Best Practices for MDR-Compliant Clinical Evaluations

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA’s expert insights and auditor feedback for medical device manufacturers.

Navigating the New MDCG Guidance Documents on CIP and IB

Discover key insights on the latest MDCG guidance for EU medical device clinical investigations, aiding in compliant CIP and IB development.

Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

The FDA’s updated guidance on race and ethnicity data collection in clinical trials calls for using OMB-standardized categories to ensure accurate demographic representation. Sponsors must create a Diversity Action Plan, with mandatory implementation for new studies within 180 days after final guidance. Participants will self-report race and ethnicity, with the option to identify as multiracial and confirm their information against medical records.

Medical Device Software: Considerations for Device and Risk Characterization

On February 2, 2024, the IMDRF released a draft guidance for public comment on Software as a Medical Device (SaMD). This document aims to unify global regulations by detailing device characterization and risk assessment for medical software. It seeks to create a shared understanding that can navigate the varied regulatory landscapes, promoting safer digital health solutions. Public feedback is encouraged to refine these critical guidelines.

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.

FDA Town Hall Series on Ethylene Oxide Sterilization and Alternative Sterilization Modalities

Explore FDA efforts to reduce EO use in medical device sterilization, the rise of VHP, and how NAMSA can assist with sterilization validation.

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Learn about EMDN updates in the new MDCG 2024-2 guidance and its impact on medical device manufacturers.

Industry Update: Quality Management System Regulation (QMSR)

Explore FDA’s new QMSR aligning with ISO 13485, simplifying compliance for device makers. Get ready with NAMSA’s expert transition guidance.

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.

MDR Vigilance: New MDCG Guidance Published

This blog covers the EU Commission’s newly published MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance.

European Commission Updates Chemical Classification and Labeling

This blog covers the latest updates to the European Commission’s harmonized classification and labeling of chemicals, including significant changes to the CLP Regulation that could impact medical devices.

Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

This blog delves into the recent amendments to the IVDR and how it will affect both transition timelines and requirements.

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 2021-6 Rev 1: Clarifications on Clinical Investigations

This blog delves into the changes in the MDCG 2021-6 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.

European Heart Journal: Randomized Controlled Trials Are Not Always the Solution

European Heart Journal Article | Published 13 December 2023 By Sara Finocchietti (NAMSA Senior Strategy Consultant, Clinical) The recent article authored by Siontis et al.1 has made considerable contributions to the ongoing debate concerning the pre-market clinical evaluation of implantable medical devices in Europe, with a particular focus on the cardiovascular domain. The study encompassed seven different … Continued

Clinical Trial Cost Analysis with Site Budget Estimates

Compliance functions and processes gain respect and recognition when something goes wrong, prompting us to question “how and why” it happened. These questions were asked after the Challenger space shuttle disaster in 1986. Several factors contributed to the disaster. NASA managers were eager to launch the Challenger due to competition with the European space agency … Continued

Your Guide to Biostatistics Outsourcing and Consulting

On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.

EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.

Auditing a QMS According to ISO 13485

Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.

May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).

NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.

UKCA: A Wait and Watch Approach?

On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

EU Commission Update : Notified Bodies Designated to MDR/IVDR

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

The IVDR Compliance Roadmap: From Start to Finish

With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.