MedTech companies face rising documentation demands, frequent regulatory updates, and shrinking timelines to support product approvals. Manual processes create delays, inconsistencies, and compliance risk.
Smartbridge’s GenAI solution uses Azure OpenAI, Azure Cognitive Search, and Power Platform to streamline regulatory work, improve accuracy, and reduce the burden on regulatory affairs teams.
This offer is designed for global device manufacturers managing complex submissions, audits, labeling, change control, and quality documentation.
Solution Overview
Smartbridge’s Microsoft-powered Regulatory Affairs Automation solution accelerator brings together Azure AI services, enterprise data integration, and Power Platform workflows to strengthen quality and compliance processes across the product life cycle. Built with Azure OpenAI, Azure Cognitive Search, Power Automate, and Power Apps, the solution provides:
- AI-Assisted Document Creation & Review: A GenAI assistant retrieves guidance, past submissions, device specs, SOPs, and regulatory references, then drafts or validates documents with higher consistency. Content examples include 510(k) summaries, labeling, PMA modules, CAPA reports, clinical evidence narratives, and change-control documentation.
- Centralized Regulatory Knowledge Hub: Azure Cognitive Search indexes structured and unstructured content to give teams instant access to historical submissions, audit findings, risk files, and design docs.
- Automated Compliance Workflows: Power Automate orchestrates approval routing, revision tracking, and controlled documentation updates across RA, Quality, and R&D teams.
- Change Impact Assessment with AI: Azure OpenAI scans engineering updates, manufacturing changes, supplier adjustments, or QMS revisions, then identifies which regulatory artifacts require action.
- Integration Flexibility with Azure Services: Connects with PLM, QMS, LIMS, and ERP systems using Azure Logic Apps and the Power Platform. Supports Veeva, MasterControl, SAP, and other MedTech systems.
Business Impact
Organizations using a Microsoft-based RA automation model see consistent gains in speed, accuracy, and compliance control.
- Reduce document creation and review time by 30-50%
- Improve accuracy of regulatory submissions and controlled documents to >95%
- Cut research and reference retrieval time to seconds using Azure Cognitive Search
- Reduce rework caused by incomplete or inconsistent documentation
- Strengthen audit readiness with consistent formatting, traceability, and content sourcing
- Give RA teams more time to focus on strategy rather than administrative work
Who Should Consider This Solution
This offer is best suited for:
- Medical device manufacturers with expanding portfolios or frequent regulatory submissions
- RA, Quality, and R&D teams managing large volumes of controlled documentation
- Organizations preparing for FDA, EU MDR, or global regulatory compliance changes
- MedTech companies seeking to introduce Azure AI capabilities while strengthening governance
- Teams needing better traceability, faster audit prep, and reduced manual review work
Why Microsoft + Smartbridge
Smartbridge brings 22+ years of experience supporting regulated industries and MedTech organizations. We are a long-standing Microsoft partner (see our current designations and specializations at Smartbridge.com/microsoft or our partner profile here in the marketplace).
Our life sciences work spans Quality, Regulatory, Manufacturing, Sales, and R&D, including custom AI assistants, cloud modernization, enterprise integration, and validation support across the device life cycle.
Get Started
Smartbridge can assess your RA processes, identify high-value automation opportunities, and build an Azure-aligned roadmap. Book a 30-minute conversation to explore how Azure AI and Power Platform can modernize your regulatory operations and reduce compliance risk.