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Global Regulatory Documents

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Device Sectors Covered

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Cloud-Based Access

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Daily Update Monitoring

Platform Features

Vistaar Capabilities & Your Benefits

Comprehensive capabilities engineered for global biopharmaceutical compliance and
regulatory intelligence.

01-regulatory-requirements-device

Regulatory requirements for Medical Devices, Diagnostics, Digital Health, SaMD, and Combination products

02-manually-reviewed

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

03-translated

Translated Guidance documents and timely alerts

04-standard-repository

Standard repository and monitoring to always be on top of upcoming changes

05-document-repository

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

06-impact-assessment-device

Impact assessment, tracking, compliance matrix, projects/tasks and reports to o manage full cycle activity from monitoring to alerts review to share/assign to members, perform global impact assessment and finalize next steps

07-project-management

Full project management functionality included as standard functionality/p>

08-cloud-based

Cloud based with intuitive easy-to-use tool

For more information about Med Device
Requirements & Compliance software

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Insights and Updates

Navigate Global Compliance with a Medical Device Regulatory Intelligence & Registration Database

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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2025

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Medical Devices – USA, Europe, Asia and ROW Regulatory News – Sept 2025

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Got Questions?

FAQ's

Find answers to frequently asked questions about Vistaar's Biopharma platform.

What is Vistaar's Medical Device & IVD Regulatory Compliance software?
Vistaar is a cloud-based software platform designed for medical device, diagnostic, digital health, SaMD (Software as a Medical Device), and combination product manufacturers. It combines a global regulatory requirements database and standards monitoring with workflow tools to manage full-cycle compliance, regulatory tracking, and quality requirements in one platform.
What types of medical devices and regulatory areas does Vistaar cover?
Vistaar covers Medical Devices, IVD/Diagnostics, Digital Health, SaMD, and Combination products. It offers manually reviewed regulatory summaries covering clinical guidelines, technical requirements, QMS/quality, testing standards, submission checklists, labeling, import/export regulations, market launches, and safety/vigilance.
How does Vistaar help manufacturers monitor standards and regulatory updates?
Vistaar features a repository of over 2 million global regulatory documents and health authority guidelines updated daily, equipped with AI-enabled search for accurate matching. It also provides translated guidance documents, timely alerts, and a dedicated standards monitoring repository to track upcoming regulatory changes.
What project management and impact assessment tools are included in Vistaar?
Vistaar includes full project management functionality standard with its cloud platform. It provides impact assessments, tracking capabilities, compliance matrices, custom reports, and project/task assignment tools to help teams review alerts, evaluate global impacts, and execute next steps seamlessly.
The First Step

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