POST-MARKET-SURVEILLANCE-AS-A-SERVICE

The post-market surveillance system is an integral part of the QMS for manufacturers of medical devices.
We assist you with all elements of the system and integrate it into the DNA of your company.

As a manufacturer of medical devices, you have to establish and maintain a post-market surveillance system (PMS) as an integral part of your quality management system. All economic operators must contribute to it throughout the entire life cycle of a medical device, making this system a crucial part in the field of medical devices.

By means of the PMS, you have to systematically gather and analyze any data with regard to the quality, performance, and safety of your devices. As THE FORCE, we take care of that – and use the collected data to:

...detect and report any trends associated with your medical device.
...check and update the clinical evaluation as well as the benefit-risk ratio.
...identify options to improve the usability, performance, and safety of the device.
...update the design and manufacturing information, the instructions for use, and the labelling, for example as part of a corrective or preventive action.
...update the summary of safety and clinical performance for implantable devices and for class III devices.
...keep the technical documentation up to date accordingly.

To ensure your PMS meets all regulatory and quality requirements and to fully integrate it into your QMS and thus into the DNA of your company, we also take care of:

...the detailed planning of these activities.
...creating post-market surveillance reports (PMSR) or periodic safety update reports (PSUR), as required for your type of product.
...establishing and maintaining a vigilance system, using IMDRF nomenclature for full transparency, and reporting all serious incidents within the given timeframe.

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