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
Have you not fully specified your needs? A telephone interview without commitment, that tells you?