Veeva MedTech $1.000

Veeva MedTech: Cloud-Based Quality and Regulatory Management for Medical Device and Diagnostics Companies

Veeva MedTech is a cloud-based solution designed specifically for medical device and diagnostics companies to streamline quality management, regulatory compliance, and commercial operations. Veeva MedTech enables organizations to manage the entire product lifecycle—from design and development to post-market activities—within a single platform, ensuring compliance with FDA, ISO 13485, ISO 14971, and other global regulatory standards. By integrating quality, regulatory, clinical, and commercial processes, Veeva MedTech helps medical device manufacturers bring innovative products to market faster, while maintaining the highest levels of safety and quality.

Veeva MedTech is part of Veeva Systems’ suite of life sciences applications and provides capabilities such as quality management system (QMS), regulatory information management (RIM), content management, and clinical operations to improve collaboration, ensure compliance, and reduce operational inefficiencies.

Key features of Veeva MedTech include:

Quality Management System (QMS): Veeva MedTech provides a unified Quality Management System (QMS) that supports the entire quality lifecycle, from design control and risk management to CAPA (Corrective and Preventive Actions) and audit management. The platform ensures that all quality processes are compliant with FDA and ISO standards, allowing companies to maintain high product quality while minimizing risks.
Regulatory Information Management (RIM): The platform helps companies manage their global regulatory submissions, approvals, and registrations with ease. Veeva MedTech provides a centralized system for tracking regulatory changes, managing submissions, and ensuring that all products are compliant with the latest regulations, including EU MDR and IVDR.
Document Control and Management: Veeva MedTech includes a robust document management system that enables teams to collaborate on regulatory, quality, and clinical documents in a secure, cloud-based environment. The system supports version control, document approval workflows, and audit trails, ensuring that all documentation is current, compliant, and easily accessible during regulatory inspections.
Design Control and Risk Management: Veeva MedTech simplifies the management of design controls and risk management throughout the product lifecycle. The platform ensures compliance with FDA 21 CFR Part 820 and ISO 14971 by enabling companies to document and manage all design inputs, outputs, verifications, and validations, as well as conduct thorough risk assessments.
CAPA and Nonconformance Management: The platform includes tools for managing CAPA, nonconformance, and deviation processes, helping medical device companies identify, investigate, and resolve quality issues. The system ensures that all CAPAs are documented and resolved in compliance with regulatory requirements, reducing the risk of non-compliance.
Clinical Operations Management: Veeva MedTech enables companies to manage clinical trials and post-market studies, ensuring compliance with global regulatory requirements and improving the efficiency of clinical operations. The platform provides real-time visibility into study progress, site management, and data collection, helping companies bring products to market faster.
Change Control and Compliance: Veeva MedTech simplifies change control processes by providing a centralized platform to track and manage product changes, ensuring that any design, manufacturing, or process changes are thoroughly reviewed and approved in compliance with regulatory requirements. The system ensures full traceability and transparency for all product changes.
Audit and Inspection Readiness: The platform provides tools for audit management, enabling medical device companies to prepare for regulatory inspections by centralizing all quality and regulatory documentation. Veeva MedTech helps companies maintain a state of audit readiness, ensuring that they can demonstrate compliance during FDA or ISO inspections.
Supplier Quality Management: Veeva MedTech includes features to manage supplier quality by tracking supplier performance, conducting supplier audits, and managing supplier qualifications. This ensures that all materials and components meet regulatory standards and product specifications.
Post-Market Surveillance: The platform supports post-market surveillance activities, allowing companies to monitor product performance, capture customer feedback, and manage adverse event reports. By providing real-time insights into product performance, Veeva MedTech helps companies continuously improve product quality and safety.
Real-Time Collaboration: Veeva MedTech fosters collaboration across teams and departments by providing a centralized platform where all stakeholders can access and contribute to quality, regulatory, and clinical data in real time. This improves transparency and ensures that everyone is working with the most up-to-date information.
Key Benefits:
- Unified quality and regulatory management system for medical device and diagnostics companies.
- Compliance with global regulatory standards, including FDA, ISO 13485, EU MDR, and IVDR.
- Real-time collaboration for quality, regulatory, and clinical teams.
- Streamlined CAPA, nonconformance, and audit management processes.
- Post-market surveillance tools for continuous product monitoring and improvement.
- Document control and management to ensure regulatory compliance and audit readiness.
- Supplier quality management to ensure product safety and regulatory compliance.
- Full traceability and transparency for design controls, risk management, and product changes.