Français
English
EU COMPLIANCE
According to the latest decrees adopted by the European Parliament and the Council of the European Union, and having made our last declaration to the ANSM on 01-12-2020, the company Fimco is self-certified CE and can continue to legally put on the market for its Class I instruments according to Directive 93/42 / EEC until May 2024.
However, Fimco already benefits from rigorous quality and regulatory monitoring, having set up a quality system since 2012 that has been improved over the years. More recently, since 2018, a quality manager position has been created to better respond to regulatory changes.
Fimco is part of a process aimed at obtaining ISO 13485 certification.
However, Fimco already benefits from rigorous quality and regulatory monitoring, having set up a quality system since 2012 that has been improved over the years. More recently, since 2018, a quality manager position has been created to better respond to regulatory changes.
Fimco is part of a process aimed at obtaining ISO 13485 certification.
Post-market surveillance - PMS
Post-marketing surveillance is a regulatory requirement for the collection and analysis of post-market information. The purpose of PMS is to monitor the safety and performance of a medical device once it is placed on the market, until the end of its life cycle.
The PMS is part of the company's QMS and is used to monitor its performance.
The purpose of the PMS is :
To update the determination of the risk/benefit ratio and improve risk management
To update information on design and manufacture, instructions for use and labelling
To update the clinical assessment
To update the summary of safety features and clinical performances
To identify the need for preventive, corrective or safety corrective measures
Identify opportunities to improve the ease of use, performance and safety of the device.
To identify and report on trends in accordance with Article 88
To update the technical documentation
In order to facilitate the process, we have set up a form, you can access it here:
We also invite you to leave your opinion on the instrumentation in the product pages, they will also be part of the data collection.
The PMS is part of the company's QMS and is used to monitor its performance.
The purpose of the PMS is :
To update the determination of the risk/benefit ratio and improve risk management
To update information on design and manufacture, instructions for use and labelling
To update the clinical assessment
To update the summary of safety features and clinical performances
To identify the need for preventive, corrective or safety corrective measures
Identify opportunities to improve the ease of use, performance and safety of the device.
To identify and report on trends in accordance with Article 88
To update the technical documentation
In order to facilitate the process, we have set up a form, you can access it here:
We also invite you to leave your opinion on the instrumentation in the product pages, they will also be part of the data collection.