current landscape & challenges
The ongoing challenge for MedTech companies is the need to keep tracking and identifying device classifications across global health authorities, which is very much a moving target.
Classifications and product definitions can vary completely between health authorities, not only leading to complexity, but also to costly Regulatory errors. Regulatory teams may even have to re-work the Regulatory filings for re-approval from a given health authority or multiple authorities.
To fulfill this role is very costly. Traditionally, country-specific device classification and registration strategy required extensive local expertise in the specific regions with either a local representation or at the very least, consulting expertise bought in to plug these regional gaps.
our automation solution
We have developed a tailored Regulatory Intelligence automation platform, specifically for the ongoing tracking of global MedTech device classifications and approvals, across global health authorities, which helps in moving away from reactive to proactive real-time MedTech Regulatory Intelligence.
Designed to be intuitive and easy to use, our automation tool set is fully up-to-date with the latest device classification information across hundreds of medical device product categories, for more than 160+ countries. Once the Device classification is identified, the Regulatory Intelligence platform also has insights available on the targeted registration process and dossier requirements for specific countries and health authorities. Access to registration pathways, dossier requirements and other Regulatory-related information is also included.
The dataset is constantly updated using back-end automation and curation by MedTech experts at Freyr. For Regulatory departments in MedTech companies, this means that they now have a real-time tracking capability for medical device registrations and device classifications worldwide.
real-world benefits
- Real-time tracking of global medical device registrations, predicate devices, device classification
- Easy to access registration pathway, dossier requirements and other Regulatory-related information
- Moving away from reactive MedTech Regulatory Intelligence to proactive real-time Regulatory Intelligence
