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

The regulatory minute: UDI & EUDAMED, what are your obligations?

UDI and EUDAMED are two KEY new features of the MDR. But practically speaking, as a manufacturer, what will you actually be required to do? Let's recap! 1) To get started, you will need to assign a UDI to the device and all higher levels of packaging and assign a...

MHRA: The end of the transition period is coming … useful new guides!

In September, the UK's MHRA published two major guidances concerning the regulatory environment for medical devices (MD) in the UK, applicable from January 1, 2021 (end of the transition period): The first one, very comprehensive, relates to the regulation of MD after...

Reprocessing of single-use devices: long-awaited common specifications !

The Commission published on August 19 the Implementing Regulation (EU) 2020/1207 laying down rules for the application of the MD Regulation as regards common specifications for the reprocessing of single-use devices. This implementing Regulation lays down rules where...

GDPR compliance and transfer of data to third countries: the CJEU rules

In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be "an adequate level of protection" for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of the levels...

Minutes of the meeting held on 19 June: something new regarding harmonized standards !

•         The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020. •         A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021. •        ...

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