nexialist

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

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

MDCG 2021-3 : Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices – March 2021

Theme Custom-Made, Adaptable and Patient-Matched medical devices Target Audience Manufacturers Products concerned MD Documents mentioned MDR (EU) 2017/745 Article 2(3), 16(1) Annex XIII IMDRF/PMD WG/N49 FINAL:2018     This document aims to answer questions...

MDCG 2021-2 : MDCG Guidance on state of the art of COVID-19 rapid antibody tests – March 2021

Theme Performance evaluation - COVID-19 Target Audience Manufacturers Products concerned IVD Documents mentioned Directive 98/79/EC Annexes I & III IMDRF/GRRP WG/N47 FINAL:2018   This new MDCG guide focuses on the state of the art of COVID-19 rapid antibody...

MDCG 2021-1 : Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional – February 2021

Theme EUDAMED Target Audience Economic Operators, Notified Bodies, Sponsors, Member-State, European Commission Products concerned MD - IVD Documents mentioned MDR (EU) 2017/745 – Article 123(3) (d) Directive 93/42/EEC Directive 90/385/EEC   This 31-page guide...

New MDCG 2021-1 Guide : administrative practices and technical solutions to be followed in the absence of EUDAMED

One of the biggest changes brought about by the new regulations on medical devices and in vitro diagnostics, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) respectively, is the creation of a European medical device database (EUDAMED). EUDAMED will...

Recent changes in the biological evaluation of your products : State of play

The normative environment for the biological evaluation of medical devices has changed significantly in recent years. The 2018 version of ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process has led to...

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