Medical devices, in vitro diagnosis, innovative therapies…

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

What are your needs?

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.

With a Click

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 2025-3 – EMDN Version History – jan 2025

Theme EMDN  Target Audience Manufacturer, competent authorities, notified bodies  Products concerned MD, IVD In January 2025, the MDCG published an excel table showing the revision history of all EMDN codes added, deleted or modified in 2024.   
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UE – MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision – jan 2025

Theme EMDN  Target Audience Manufacturer, competent authorities, notified bodies  Products concerned MD, IVD In January 2025, the MDCG published a document presenting the results of the analysis of submissions made during the annual procedure for revising the European...
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UE – MDCG 2025-1 – EMDN Ad hoc procedure – jan 2025

Theme EMDN  Target Audience Competent authorities, notified bodies  Products concerned MD, IVD In January 2025, the MDCG published a model form for submitting proposals under the ad hoc updating procedure for the European Medical Device Nomenclature (EMDN).   As a...
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Liability for defective product Directive (EU) 2024/2853: what’s new for MD and IVD manufacturers?

On the eve of its 40th anniversary, the Liability for defective product Directive is being renewed to adapt to technological innovations, combat legal inconsistencies and ensure legislative consistency within the EU.   Published in the Official Journal of the European...
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Read our publications
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