Benefits for manufacturers of life science products
FSCA.com facilitates the manufacturer to play an active role during the post-market phase. When the manufacturer decides for a Field Safety Corrective Action, close monitoring of the implementation at the level of healthcare providers is required. Using FSCA.com the manufacturer collects FSCA status data from the healthcare providers. With this information the manufacturer is able to finalize the FSCA and to cooperate with the national competent authorities in charge of vigilance and market surveillance activities.
FSCA.com has proven to reduce the processing time of field safety corrective actions significantly. Manufacturers can use the gained time by focusing on the real issue: patient safety and client relationship.
FSCA.com provides a solid and reliable basis for implementation of the published field safety notice. All actions taken by the healthcare providers can be monitored at any time. This all in a secured environment.
FSCA.com logs all correspondence with the affected healthcare providers. A manufacturer can create a comprehensive report at any time.
Great data overview
Relevant data and information gathered in the post-market phase, as well as lessons learned from any implemented preventive and/or corrective actions, should be used by the manufacturer to update any relevant part of technical documentations, such as risk assessment, clinical evaluation and should serve the purpose of transparency.
The portal provides several reporting views. Results of the actions taken by healthcare providers are shown graphically and in tables.
Notifications to the healthcare providers are given when actions are not taken in a timely manner.
A manufacturer using this portal operates in a secured environment. All data are confidential and for the eyes of the manufacturer only.
No download needed
There is no need to acquire a software package. FSCA.com is cloud based.
Our services are fully compliant with the European regulations with regard to Data Protection, valid as from May 2018.
Attn.: Data Protection Officer
PO Box 7890, 1008 AB Amsterdam - The Netherlands
Tel. : +31-6-51456938
By e-mail : dpo@FSCA.com
In order to minimize risks or prevent incidents related to medical devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions. This shows how the FSCA.com portal facilitates this process:
The supplier publishes a Field Safety Notice (FSN)
After registration in the FSCA.com portal, the supplier operatates in a secured environment. A new FSN is uploaded in the system easily. When the FSN meets all requirements of the FSCA.com portal, the FSN is sent to all affected healthcare providers. In addition a writing to confirm the FSN is sent to the senior management of the healthcare provider. Part of the procedure is the option to offer alternate parts to the healthcare provider, in order to ensure continuation of the healthcare process.
The healthcare provider takes measures requested in the FSN
A healthcare provider that is affected by the published FSN receives a message on behalf of the manufacturer. The healthcare provider is requested to take the defined measures and to fill in a sheet to confirm the actions taken. The manufacturer monitors this process using its secured account of the portal. After submitting the sheet the healthcare provider receives a confirmation message for its own file.
Finalizing the FSN
Based on the defined due date reminders are sent to the healthcare providers that have not yet responded. The manufacturer receives a notification when all healthcare providers have submitted their data sheets. After collecting all data from the healthcare providers, the manufacturer finalizes the FSN. A comprehensive report including all correspondence with the healthcare providers can be downloaded and sent to the competent authority.
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