Unlocking Potential: The Vital Role of GSPR in Medical Device Development
The central role of General Safety and Performance Requirements (GSPR) in Technical Files (TF) cannot be overstated. The relationship between GSPR and TF is symbiotic. GSPR sets the standards and requirements, and the TF acts as the repository of evidence that the medical device complies with these standards.
GSPR is more than just a checklist that you are required to fill before certification of your product. Work on addressing GSPR requirements should commence early in the development phase of a medical device. Since GSPR significantly influences the design, development, and testing phases of a medical device's lifecycle, only the early integration ensures that safety and performance considerations will be are embedded in the design and development processes.
For ensuring GSPR compliance you are required to consult applicable regulations, take into account harmonized and industry-specific standards, refer to international and national benchmarks, seek guidance from regulatory experts, and stay vigilant for any updates. A crucial aspect of the process involves documenting your compliance strategy in the TF and actively engaging with notified bodies when necessary. This diligent approach ensures a well-informed strategy for GSPR compliance, culminating in the successful certification of your medical device.
Moreover, the TF should be continuously updated throughout the device's lifecycle to reflect changes and ensuring ongoing compliance with GSPR and regulatory expectations. This dynamic relationship between GSPR and the TF is essential for maintaining the safety and performance of your medical devices in the market.
The Starodub team brings vast expertise in a diverse range of medical devices and is ready to assist you in developing a GSPR compliance strategy and engaging with notified bodies when necessary. Whether in the early development phase or throughout the lifecycle, we offer comprehensive support to ensure regulatory compliance of your medical devices.