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

Less than 16 months before IVDR date of application, have you gotten a head start ? It’s time to get moving !

  The new in vitro Diagnostic Regulation (EU) 2017/746 (IVDR) which replaces the IVD Directive (98/79/EC), entered into force on May 25th 2017, and will enter into legal application by 26 May 2022 after a 5-yeartransition period. Team-NB published a consideration...

Commission Notice regarding temporary extraordinary measures, including remote audits

  Given the exceptional circumstances of the COVID-19 epidemic, the European Commission published a Notice on 11/01/2021 that temporarily allows notified bodies to perform remote conformity assessments of manufacturers QMS under the MDR/IVDR. Certain conditions...

MDCG 2020-17 : Questions and Answers related to MDCG 2020-4 – December 2020

Theme COVID-19 - Audit Target Audience Notified Bodies, Manufacturers, Subcontractors Products concerned MD, IVD Documents mentioned MDCG 2020-4 : Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine...

MDCG 2020-18 : MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers – December 2020

Theme UDI - EUDAMED Target Audience Manufacturers Products concerned Spectacle lenses and ready readers Documents mentioned MDR (EU) 2017/745 Article 10(7) Chapter III : Article 27, Article 27(3), Article 29, Article 31 Annex VI   In this document, the Medical...

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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