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

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 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 – December 2022

Theme Substantial modification of performance study Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66(1) Article 70(1) Article 71 Documents mentioned MDCG 2022-19   As the EUDAMED database is...

MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 – December 2022

Theme Application/notification for performance studies Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66 Article 69 Article 70(1) Documents mentioned MDCG 2022-12   As the EUDAMED database is...

MDCG 2022-18 : MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – December 2022

Theme Legacy devices Target Audience Manufacturers,  Notified bodies Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2020-3 MDCG 2021-25   This position paper concerns legacy medical devices, i.e. devices with an MDD or AIMDD...

MDCG 2022-17 : MDCG position paper on ‘hybrid audits’– December 2022

Theme Hybrid audits Target Audience Notified bodies, Manufacturers Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-4 MDCG 2020-17 MDCG 2022-14   This MDCG document clarifies the definitions and...

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