Medical devices, in vitro diagnosis, innovative therapies…

We work with you on all compliance, quality, regulatory issues and product/market development strategy.

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Experts at your side and state-of-the-art tools at your service

Monitoring and Regulatory Strategy, Design and Development, Post-market Monitoring, Audit, Training, Process Validation, Clinical Evaluation, Electrical Safety…

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A regulatory monitoring in a high-demand sector

Receive news about your sector, the latest regulatory developments, our analysis and personalized advice

Discover nex'inform

01

Our missions

Nexialist is a consulting company specializing in regulatory intelligence and compliance of health products.

We support customers in all stages of their processes: regulatory watch, consulting, audits, technical files, compliance, training, etc.

Our teams of experts and our methods adapted to each need make nexialist a reference in France and Europe.

02

Our areas of expertise

Regulatory strategy . QMS . Technical file STED . Internal and external audits . CE marking . Emergency solutions . Design and development . Regulatory and standards monitoring . Process validation . Clinical assessment . Post market surveillance . Support for international development

03

Our clients

Manufacturers, distributors and subcontractors: medical devices / in vitro diagnostics / Innovative Therapies, Medtechs and Biotechs, Competitiveness pole, Notified bodies, Research centers.

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ALL OUR SERVICES

nex’ strategy
Regulation strategy
nex’ design
Design & Development
nex’ pms
Post-market surveillance
nex’ audit
Internal and external audit
nex’inform
Regulatory & normative monitoring
nex’ reg
Regulatory Matters
nex’ file
Technical file
nex’ learning
Learning
nex’ quality
Quality management system
nex’ elec
Electrical safety
nex’ valid
Process validation
nex’ med
Clinical evaluation
nex’ sos
Emergency situations

nexialist, it is an expertise and publications to enlighten you in your regulatory processes

Summaries of MDCG documents

This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...
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UE – MDCG 2026-3 – 2026 EMDN Version History – april 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide is a log of the changes made during the 2025 annual revision of the EMDN (transition from v.2025 to v.2026). It lists only the codes that have changed,...
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UE – MDCG 2026-2 – 2025-2026 Annual Revision Change Log – April 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide presents the complete EMDN nomenclature in version 2026. This file contains all active and inactive EMDN codes, along with their history. It includes:  The...
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UE – MDCG 2026-1 – Summary of EMDN 2025 Submissions and outcome of annual revision – april 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide presents the results of the analysis of submissions made during the annual review of the European EMDN nomenclature in 2025.  It lists the submissions: ...
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UE – MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices – December 2025

Theme Post-market surveillance  Target Audience Manufacturers Products concerned MD, IVD  The purpose of this guide is to:    Introduce the post-marketing surveillance (PMS) system   Describe the content and structure of the PMS plan   Outline the main activities...
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