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

How the MDR will impact your regulatory watch

Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...

Successfully preparing for remote audits of your quality management systems

Current travel restrictions, combined with the necessity to maintain regulatory certification programs, have driven certification bodies to find alternative methods of assessing the conformity of medical device manufacturers’ quality management systems (QMS). Various...

News and Updates

Welcome in the news and updates section! You will discover here everything about the MD industry and even more. Our Knowledge Management team will present you its bests articles & the Marketing our corporates news. You will find easily all your looking for in this...

The COVID-19 pandemic and face masks: overview of the current situation

As the world continues to be hit hard by the COVID-19 pandemic, the European Union is facing shortages of necessary personal protective equipment (PPE) and medical devices, such as face masks. Given the surge in demand for these products, legislative measures have...

Latest and final version of the regulation on in vitro diagnostic medical devices

The European Council published, on the 22nd February 2017, the final text of the Regulation on medical devices. This text changes and replaces the proposal for a regulation published on the 9th august 2016, which had obtained a political agreement on the 20th...

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