SERVICES
Vigimed Consulting supports medical device industry players through their
quality & regulatory issues.
OUR SERVICES
PRODUCT COMPLAINTS MANAGEMENT
Bringing us our expertise to integrate an efficient, coherent, global complaints management system articulated with all the processes of your QMS and existing tools.
Optimized process implementation – Complaint Handling Unit
Management of the system as a whole, from its registration to its closure, including the evaluation of its reportability
Assistance in the development of an electronic complaints management module
VIGILANCE
We bring you a solution adapted to the needs of your company. A global solution for your medical device vigilance system
Assistance in drafting quality agreements with distributors in terms of materiovigilance
Local materiovigilance correspondent
Compliance of your process with the various regulations: EU-CA-US and WW
Assessment of reportability and declarations to health authorities
Management of security corrective measures (reminder, security notice)
Support for the reaction and submission of medical device vigilance declaration reports
POST MARKET SURVEILLANCE
Management of your PMS System as a whole
Development of PMS / PMCF Plans
Writing PMS / PMCF Reports
QUALITY MANAGEMENT
We support you on all aspects of your quality system as a whole
NC management
CAPA management
Risk management
Supplier quality management
PRRC – PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
The European Medical Device Regulation MDR 2017/745 (Article 15) requires manufacturers to have at least one compliance officer within their organization with the required expertise in the field of medical devices. Micro and small enterprises are not required to have, within their organization, a person responsible for ensuring compliance with the regulations, but such a person is permanently and without interruption at their disposal.
Vigimed Consulting can perform this role for you partially as follows:
Verification of the conformity of the devices with regard to the quality system in place
Good maintenance of the technical file
Obligations relating to post-market surveillance are complied with
TRAINING
We provide a wide range of training modules in the management of materiovigilance complaints that are efficient and adaptable to the needs of your organization.
We can also provide this training to your organization or your subcontractors.
Some examples of training modules available:
Management of complaints and materiovigilance in the QMS
Materiovigilance pre/post CE marking
Materiovigilance: EU regulations – MDSAP – China
ISO13485
MDR 2017/745
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