Our solutions

  • Mastery of ISO9001 and ISO 13485 quality standards

    • IRCA certified auditor

    • ISO 9001

    • ISO 13485

    • ISO 14001

    • OHSAS 18001

  • Outsourcing of your internal audits and conditioning for certification.

  • External audit of your critical suppliers and outsourced sub-contracting in particular in China/Europe.

  • Audit on specific points or on your entire system.

  • Follow up on corrective actions and determine an improvement plan.

  • Sensibilization of the main actors of your company about quality.

Internal quality and regulatory audit 

  • Few internal auditors to ensure mastery of the QMS.

  • You want to bring an outside view of your system.

  • Need support in preparing for audits by the authorities and your key customers.

  • You want to audit your critical suppliers.

  • Audit of outsourcing subcontracting in France and China.

Our solutions

  • Implementation of a continuity plan for the function of quality manager on an interim basis, or eventually by dedicating a few days per month for this follow-up.

  • The mission letters will be defined on a case-by-case basis according to the organization and the level of the quality system set up and this after having carried out a diagnostic audit.

Outsourcing quality services

  • You need an operational QA manager  several days a month (break , holidays or other).

  • You are having difficulty replacing your quality manager after he or she has left the company.

  • You wish to increase the qa function during an overload of activity. 

Our solutions

  • Implementation of systems: ISO 9001 /13485/14001 up to the CE marking of your products.

  • Sensibilization and training of the main players in your company on quality and regulations affairs.

  • Training of internal auditors.

Implementation a QA system

  • You wish to set up a Quality Management System following a request from your customers or to respond to the market in particular for medical devices.

 

  • You are a distributor of medical devices and you have to meet the requirements of the new regulation.

  • Setting up a continuity plan for the function of quality manager on a temporary basis, or in the long term by dedicating a few days per month for this follow-up.

Our Solutions

  • Help in writing technical files for classes I ,IIA ,IIB.

  • Monitoring of regulatory watch (standards, MEDDEV, MDR etc.).

  • Qualification to perform the function of monitoring compliance with regulations.

  • Regulatory compliance following inspection.

  • Coordinate with health authorities (responses to medical devices vigilance). 

Regulatory affairs

  • You want to put a new device on the market and subcontract the production of the technical file according to the new regulation for its CE marking.

  • Outsource regulatory monitoring and have a person in charge of ensuring compliance with regulations.

  • Perform an audit of your existing technical documentation.

  • Regulatory assistance following an inspection by the competent authorities. 

Our Solutions

  • Decision support for the choice of sterilization process.

  • Management and management of critical process validations with technical expertise (sterilization, packaging, etc.)

  • Audit of subcontractors.

  • Software validations.

  • Validation of clean room cleaning.

Validation of specific processes

  • You hesitate about the choice of sterilization of your product and its packaging.

  • You wish to control manufacturing conditions, particularly in clean rooms.

  • Outsourced subcontracting validation.

 
 
 
 
 

Our Solutions

Rédaction de dossier technique ou aide à la rédaction (coaching) :

  • Le dossier de gestion des risques selon la norme ISO 14971 ;

  • L’évaluation préclinique (incluant le rapport de biocompatibilité selon la norme ISO 10993) ;

  • Le rapport d’évaluation clinique selon les guidelines MEDDEV 2.7.1 rev4 ;

  • Le dossier d’ingénierie de l’aptitude à l’utilisation selon la norme ISO 62366 ;

  • Le dossier de production ;

  • Le dossier de conception ;

  • Les exigences essentielles.

Audit de dossiers techniques

Clinical evaluations

  • Aide à la mise en place du système qualité en particulier chez les distributeurs de matériels médicaux.

  • Répondre à la demande de vos clients.

  • Assurer le contrôle de vos fournisseurs critiques.

  • Aide aux demandes des autorités et organismes notifiés.