Global Regulatory agencies want to know how you are using Software in your products, what role it’s playing and how HCP / end users can rely on it. While some countries have formed good framework to regulate these, other countries are still at starting stages and some created guidance/regulations that are not well thought out. All these aspects impact companies on their global plans of having their products available in different markets while complying with local regulations.
How Vistaar can Help?
VISTAAR analyzes all global digital health Regulatory requirements pertaining to Software as Medical Device/Diagnostic (SaMD), Software used in Devices, IOT and other categories and makes this information available to you in the form of reports, searches, alerts, and monitoring).
Vistaar Expertise
- Precompiled and manually reviewed healthcare regulatory requirements such as registration requirements, Testing standards, cyber security rules, data confidentiality, privacy and other data points
- Compare country details and download different parameters side-by-side
- Tracks changes in regulations and guidelines and send alerts
