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 2021-8 : Clinical investigation application/notification documents – May 2021

Theme Clinical investigations Target Audience Sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1   This guide lists all the useful documentation for clinical investigation requests in accordance with the MDR (EU) 2017/745 and...

MDCG 2021-7 : Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices – May 2021

Theme COVID-19 Tests Target Audience Manufacturers, Authorised representatives Products concerned IVD Documents mentioned IVDR (EU) 2017/746 MEDDEV 2.12-1   This document is intended for manufacturers and authorised representatives of in vitro diagnostic medical...

MDCG 2021-6 : Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation – April 2021

Theme Clinical investigation Target Audience Sponsors (recital 49) Products concerned MD Documents mentioned MDR (EU) 2017/746 Chapter VI Directive 90/385/EEC Directive 93/42/EEC ISO 14155 :2020   Aimed primarily at sponsors of clinical investigations, MDCG...

MDCG 2021-5 : Guidance on standardisation for medical devices – April 2021

Theme Harmonised standard, conformity assessment Target Audience Manufacturers, Subcontractors, Notified Bodies Products concerned MD and IVDMD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC...

MDCG 2021-4 : Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 – April 2021

Theme Transitional provisions – Conformity Assessment - EURL Target Audience Manufacturers, Notified Bodies Products concerned Class D IVD Documents mentioned IVDR (EU) 2017/746   This guide in the form of questions and answers provides indications on how to...

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