MedTech to Market, Accelerated
An eQMS platform and implementation services purpose built for MedTech startups.
MedTech to Market, Accelerated
An eQMS platform and implementation services purpose built for MedTech startups.
SmartDataTrace and QuickVault by Veeva
Our partner, Veeva, provides a proven, start-up ready eQMS platform.
SmartDataTrace delivers the methods and services that make it work in the real world.
Turn compliance risk into a digital advantage
Compliance risks don't just slow MedTech start-ups down, they derail them. Hidden gaps cause rework and delays - often surfacing when they can do the most damage.
Traditional eQMS implementations demand heavy configuration, validation, documentation and cost - delaying adoption and forcing teams to rely on spreadsheets and shared drives never designed for compliance.
SmartDataTrace pair services that drive adoption with a pre-configured platform from a strategic vendor - to support your innovations.
The SmartDataTrace Approach
We help MedTech startups adopt quality systems using principles founders already understand — product design and risk-based execution. By treating the QMS as a designed system and using platform capabilities in novel ways, we extend transparency, traceability, and control across the business—embedding quality into how companies operate from day one.
Smart Solutions
We combine proven solutions with MedTech specific implementation methods that prioritize adoption over documentation.
Teams get up and running faster with lower risk and a solution they actually use.
Connected Data
We replace spreadsheets and file shares with a single, connected source of truth inside the eQMS. Data is structured, validated, and traceable by design—reducing integrity risk and simplifying audits.
Real-time Traceability
Strategy, risks, requirements, activities, and evidence are linked in real time. Founders and quality leaders get continuous visibility into readiness and compliance—without last-minute fire drills.
Services we offer
ISO 13485 by Design
Inspection Readiness Inside
Data Migration by Design
We provide a framework , using design controls, that allow you treat the QMS itself as your first product - designed, built, tested and improved by the organisation.
Use the system implementation as a practical learning environment where teams become familiar with ISO 13485 principles before applying them to real-world innovations.
Data Migration by Design
Inspection Readiness Inside
Data Migration by Design
Clean, validated, traceable data from day one—treating data as a regulated asset.
Inspection Readiness Inside
Inspection Readiness Inside
Inspection Readiness Inside
Continuous inspection readiness with ownership, evidence, and real-time visibility.