Your partner for medical device compliance

Customized solutions

For the compliance of your Medical Devices

Medical devices, in vitro diagnosis, innovative therapies…

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

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…

A regulatory monitoring in a high-demand sector

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


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.


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


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


nex’ strategy
Regulation strategy
nex’ design
Design & Development
nex’ pms
Post-market surveillance
nex’ audit
Internal and external audit
Regulatory & normative monitoring
nex’ reg
Regulatory Matters
nex’ file
Technical file
nex’ 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...

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

Theme European Medical Device Nomenclature (EMDN)  Target Audience All the actors  Products concerned MD, IVD  Documents mentioned RDM (UE) 2017/745 – article 26  RDIV (UE) 2017/746 – article 23  This guide relates to the :  revision of the European Medical Device...

MDCG 2024-1 Guidance on the vigilance system for CE-marked devices – DSVG 00 Device Specific Vigilance Guidance Template

Theme Vigilance  Target Audience Manufacturers Products concerned Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants  Documents mentioned MDR (EU) 2017/745 – articles 87 et 88, 92  IVDR (EU) 2017/746 –...

MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence

Theme Clinical investigation exemption, demonstrating equivalence  Target Audience Manufacturers Products concerned Class III and implantable MD  Documents mentioned MDR (EU) 2017/745 – Article 61(4)-(6)  MDCG 2020-5   MDCG 2020-6   MDCG 2020-8  This MDCG guide aims...

MDCG 2023-6 – Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies​

Theme Clinical evaluation, demonstrating equivalence  Target Audience Manufacturers, notified bodies  Products concerned Products without an intended purpose listed in Annex XVI of MDR  Documents mentioned MDR (EU) 2017/745 - Annex XIV, Annex XVI  Implementing...

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