Unlike other industries, device manufacturers give equal weightage to Regulatory, Quality and Compliance requirements. When introducing new products or making product changes or ensuring country compliance, manufacturers have to assess all these factors simultaneously.
At Vistaar, we combine our technology with our global team of Analysts and SMEs who review and summarize global regulations, guidance and standards.
Vistaar Capabilities & your Benefits:
- Regulatory requirements for Medical Devices, Diagnostics, Digital Health, SaMD, and Combination products
- Manually reviewed regulatory summaries covering clinical, technical, QMS/Quality, market launches, testing standards, submission checklists, fees, labeling, import/export, marketing, safety/Vigilance, life cycle requirements, and many more areas in a granular manner
- Translated Guidance documents and timely alerts
- Standard repository and monitoring to always be on top of upcoming changes
- Over 2 Million Global regulatory document repository of health authorities’ regulations and guidance, updated daily and provided to you with AI-enabled search for faster and better match
- Software to manage full cycle activity from monitoring to alerts review to share/assign to members, perform global impact assessment and finalize next steps
- Full project management functionality included as standard functionality
- Cloud based with intuitive easy-to-use tool
- Country translations handled with in the tool
- If needed, combine with Services for any of your projects that need our team’s time or expertise
