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
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.
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
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
Design & Development
Internal and external audit
Regulatory & normative monitoring
Quality management system