VIGIMED CONSULTING
Expertise in the medical device industry
VIGIMED CONSULTING
WHO ARE WE ?
With more than twelve years of business expertise in the field of quality and regulatory assurance in the medical device industry, Vigimed Consulting brings you its expertise in the implementation, deployment, maintenance and improvement of your complaints handling and medical device vigilance management process.
Our strong experience of the various issues that medical device industry players may face makes our strength to bring you the most effective solutions to improve your Quality Management System as a whole.
OF OUR MISSIONS
COMPLAINTS MANAGEMENT
The complaint management process is one of the main mirrors reflecting the behavior of your product on the market through the prism of incidents, serious or non-serious, and other customer feedback to which it may be associated. It is a major source of information relating to the safety and performance of your medical devices after they have been marketed.
The quality of the information captured will depend on the robustness of this process, its deployment within your company as well as the resources (human and technical) that will be allocated to it.
Integrate the importance of this process is crucial to meet the regulatory obligations of medical device vigilance and post-marketing surveillance (PMS). European Medical Device Regulation 2017/745 places particular emphasis on these concepts. An integral part of reactive PMS, this process by its cross-functionality, impacts the entire quality system and participates in its continuous improvement.
OUR SERVICES
Vigilance System
We bring you a solution adapted to the needs of your company. A global solution for your medical device vigilance system.
Complaint Handling
We bring our expertise to integrate an efficient complaints management system, articulated with all the processes of your QMS.
Post Marketing Surveillance
To control your PMS System as a whole. To develop PMS / PMCF Plans and write PMS / PMCF Reports.
Quality Management
We support you on all aspects of your quality system as a whole; from NC management to all-risk management and supplier quality.
PRRC
We bring our expertise and advice to ensure the role of ensuring compliance with regulations in the field of medical devices.
Training
A wide range of training modules to offer you in the management of materiovigilance complaints, adaptable to the needs of your organization.
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