EXTEDO’s SafetyEasy MD offering is a comprehensive and cost-effective solution designed to streamline your device vigilance and post-market surveillance processes. It enables you to classify, create, review, submit and maintain device vigilance data and adverse event reports within a single, easy-to-use application.
Ensuring compliance with the latest medical device safety regulations
Built specifically to support the FDA 21 CFR Part 11, EU GMP Annex 11 SafetyEasy MD handles the reporting and management of all serious and non-serious adverse events. Its future-proof approach can generate PSUR and DSUR documentation. In addition, SafetyEasy MD also enables you to readily track and monitor the status of workflows. Through email notifications and online dashboards
SafetyEasy MD provides users with reminders about imminent activities they
need to perform. This helps ensure that submission deadlines are met and
other legal obligations are not overlooked.
Cloud-based device vigilance service
As a secure, cloud-based service, SafetyEasy MD is lightning quick to implement and requires no customization. In many instances, SafetyEasy MD can be configured and validated within two weeks. Its simple, intuitive and user-friendly interface speeds user adoption and eliminates the need for extensive training.
Used by more than 80 organizations across 85 countries, SafetyEasy MD is the simplest and most cost effective way to ensure effortless compliance with current and future medical device safety regulations. SafetyEasy MD is compliant with the following regulatory guidelines: ICH, EMA and FDA regulations.