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DEM CONSEIL est un cabinet de conseil spécialisé dans l'accompagnement des entreprises du secteur des dispositifs médicaux.
Evelyne et Maxime vous apportent un conseil technique et réglementaire pour :
- vos dossiers de conceptions ( définition des données d'entrée et sortie, aptitude à l'utilisation, verification/validation, evaluation clinique, dossier de gestion des risques)
- le transfert de conception, l'industrialisation et la maitrise de votre production ( spécifications de fabrication, aide au choix de sous traitants...)
- vos dossiers d'évaluation du risque biologique (ISO 10993-1)
- vos validations procédés et logiciels ( ISO 19227, ISO 11377, IS0 11737, ISO 11607,...)
- vos audits (préparation à des audits/inspections, audits sous traitants, audits internes). Evelyne est auditrice certifiée ICA.
- la gestion de vos changements de conception et procédés
DEM CONSEIL est certifié Qualiopi pour ses actions de formation.
Retrouvez la liste des formations disponibles sur www.demconseil.com
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Our mission is to help medical devices companies with technical and regulatory assistance. We can help you with :
- design control ( design input and output definition, usability program, verification/validation strategy, clinical evaluation, risk management, technical file compilation)
- design transfer and production and process control ( manufacturing specifications, adequate supplier selection...)
- biological safety evaluation
- process and software validation
- audits (preparation to audits and inspections, suppliers audits, internal audits)
- design and process changes
Company Details
- Employees
- 3
- Founded
- -
- Address
- 179b, Rue Des Murlins, Orléans,centre-Val De Loire 45000,france
- Industry
- Medical Equipment Manufacturing
- Website
- demconseil.com
- Keywords
- dispositif médical, Qualification/validation, Dossiers de conception, Audits, Dossier d'evaluation du risque biologique, transfert de conception.
- HQ
- Orléans, Centre-Val de Loire
Dem Conseil Questions
DEM CONSEIL's website is demconseil.com
DEM CONSEIL's LinkedIn profile is https://fr.linkedin.com/company/demconseil
DEM CONSEIL has
3 employees.
View email and phone details for 3
employees at DEM CONSEIL.
DEM CONSEIL's industry is
Medical Equipment Manufacturing
DEM CONSEIL's top competitors are
Dm Conseil,
Philomec,
Mke Centrifuge Manufacturer,
Anaxi Swiss,
Peki Scientific Limited Company,
Imetronic,
Naqtronic,
Réseau Du Dispositif Médical En Nouvelle-Aquitaine (Rdm-Na),
Amion Llp,
Champion Air Testing.
DEM CONSEIL's categories are Medical Equipment Manufacturing
DEM CONSEIL's founding year is 2019
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Top DEM CONSEIL Employees
-
Maxime Chenu
Gérant - Consultant Dispositifs…
Orléans, Centre-Val De Loire, France, France -
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