Nexialist is a consulting firm specializing in regulatory intelligence and compliance of healthcare products
In the healthcare field, regulations are constantly being tightened and their application has become the number one challenge for company managers!
In this context, being accompanied by nexialist is to ensure, thanks to a multidisciplinary team of experts and proven working methods :
. to deal with regulatory affairs in complete serenity, by anticipating regulatory changes,
. to increase the competence of internal teams through adapted training programs,
. accelerate the access of products to the market and maintain them over time
. to control its technical documentation gathering the proofs of conformity
. to implement a quality system that complies with organizational requirements
. transform regulatory requirements into business opportunities and thus reintegrate regulations into the heart of the company's strategy
Our areas of expertise :
Regulatory strategy. QMS. Product compliance and STED technical file. Internal/external audits. Training. Electrical safety. CE Marking. Emergency missions. Design and development. Regulatory and normative watch. Process validation . Clinical evaluation . Post market surveillance . Optimization of the marketing. Support for international development.
Our clients :
Manufacturers, distributors, and subcontractors: medical devices / in vitro diagnostics / innovative therapies
Medtechs and Biotechs
Competitiveness clusters, Notified Bodies, Research centers
www.nexialist.fr
and also follow us on Twitter : @Nexialist_
Company Details
- Employees
- 28
- Founded
- -
- Address
- Le Forum Bat B, 515 Avenue De La Tramontane,canada
- Phone
- +33 (0)4 42 01 60 29
- co****@****list.fr
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- nexialist.fr
- Keywords
- Dispositifs médicaux, Diagnostic, Conformité produit, Qualité, Medical Devices, MedTech, Stratégie réglementaire, SMQ, Dossier technique STED, Audits internes/externes, Formations, Sécurité électrique, Marquage CE, Missions d’urgence, Conception et développement, Veille réglementaire et normative, Validation des procédés, Evaluation clinique, Post market surveillance, Optimisation de la mise sur le marché, Accompagnement au développement international.
- HQ
- La Ciotat
Nexialist Questions
Nexialist's helpline number is +33 (0)4 42 01 60 29
Nexialist's website is nexialist.fr
Nexialist's LinkedIn profile is https://fr.linkedin.com/company/nexialist
Nexialist has
28 employees.
View email and phone details for 28
employees at Nexialist.
Nexialist's industry is
Business Consulting and Services
Nexialist's top competitors are
Invest In Provence By Provence Promotion,
Roxlor,
Regulatory Affairs Professionals Society (Raps),
Archeon Medical,
Lattice Medical,
Biotika®,
Vygon,
Hemarina,
Urgo Group,
Snitem.
Nexialist's support email address is contacts@nexialist.fr
Nexialist's categories are Business Consulting and Services
Nexialist's founding year is 2006
