Unlike other industries, device manufacturers should give equal weightage to Regulatory, Quality and Compliance requirements. When introducing new products or making product changes they have to assess all three factors simultaneously.
How Vistaar can Help?
At Vistaar, we utilize AI powered technology, in conjunction with our global team of Analysts and SMEs who review and align our broader and deeper datasets to meet your specific needs(in the form of customized regulatory intelligence reports, targeted searches, timely alerts, and comprehensive regulatory monitoring services)
Vistaar Expertise
- 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
- Compare countries or specific areas side-by-side (and download in the format of your preference)
- Compliance requirements (ROHS, REACH, etc)
- Global up-to-date technical standards and subscribe to alerts
- 1.4 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
- Global clinical trials gathered from global registries for you to see all clinical activity
