SafetyEasy MD - Medical Device Vigilance Software

The most cost-effective solution for effortless medical device compliance

Understanding the risks and benefits associated with modern medical devices brings with it the need for more efficient and effective vigilance solutions. Ensuring this clear picture protects both patients and manufacturers against unnecessary risks and ensures regulatory compliance.

Maintaining device vigilance data is a mandatory regulatory requirement. Yet despite the undoubted benefits it brings, it can be a highly time intensive and costly process that ultimately contributes little to bottom line revenue. As such, the need to minimize these costs, yet deliver a best practice monitoring and reporting workflow is crucial to your business success. 

Benefits

  • Readily monitor device safety activities
  • Compliant with latest EU 2017/745 medical device regulations
  • Single database for device vigilance data
  • Cloud-based platform with no need for customization
  • Easy-to-use with minimal training effort

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.

 

Downloads

SafetyEasy MD Product Information

Pharmacovigilance Services

EXTEDO also offers Pharmacovigilance Business Process consulting services, which are tailored specifically to your needs. Based on many years of experience working with drug safety rules and regulations, EXTEDO´s team will help you to identify gaps in your pharmacovigilance processes and help you to develop and implement appropriate strategies PSMF to resolve them.

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Technical Consulting

Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.

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Education & Training Services

To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.

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