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

Souha Dachraoui

I worked as a physiotherapist for two years, after that I worked as a medical representative for a pharmaceutical laboratory. Then I decided to broad my skills and get a degree in Engineering and Ergonomics of Physical Activity before completing my academic career...

MDCG 2023-4 Medical Device Software (MDSW) –Hardware combinations – October 2023

Theme Software Target Audience Manufacturers Products concerned MDSW (Medical device software) Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2019-11MDCG 2020-1MDCG 2019-16 This guidance examines and clarifies the specific regulatory aspects that...

Laetitia Frank

After more than 20 years’ experience in medical devices and in vitro diagnostic medical devices fields, I joined nexialist team in November 2022. With an academic background in biomaterials, I had the opportunity to work in different environments : Research...

MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023

Theme Vigilance Target Audience Competent authorities, economic operators, and other interested parties Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MEDDEV 2.12/1 rev.8Regulation (EU) No 1025/2012EN ISO 15223-1:2021Manufacturer...

MDCG 2023-2 List of standard fees – January 2023

Theme List of standard fees Target Audience Notified bodies Products concerned MD, IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-6Recommendation 2003/361/EC Regulations (EU) 2017/745 and 2017/746 require Notified Bodies to...

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