ISO 82304-2 Assessment

Accelerate your journey to ISO 82304-2, boost your global sales

ISO 82304-2 sets quality requirements for health apps to establish trust from healthcare decision makers. We help verify and meet these requirements, ensuring your app is up to standard.

Is your app healthy & safe, easy to use, secure, and robust? Obtain your ISO 82304-2 gap report with actionable insights for quicker compliance.

Startups benefit from early action

Many ISO 82304-2 controls involve straightforward IT decisions best implemented early in development.

With our guidance and support, you can make informed decisions sooner, facilitating later certification and avoiding the need for major reworks.

Minimize compliance risks

We reduce risk by sharing knowledge about the needs and decision processes of healthcare organizations.

Our approach saves you time, providing pre-mapped milestones to streamline execution without the need to delve into the minutiae.

ISO 82304-2 Gap Report

Our report helps you identify gaps and improvement areas for each quality indicator to help you reach compliance more rapidly.

Covered Topics

  • Healthy & Safe
  • Easy To Use
  • Secure Data
  • Robust Built

Prioritized Controls Checklist

  • Actionable steps to achieve controls.
  • Priority level for each controls.
  • Advices & insights.


ISO 82304-2
Gaps & Roadmap

  • ISO 82304-2 Gap Report
  • Prioritized Controls Checklist
  • Monthly follow-up meeting
  • 4 months access to Gaps & Roadmap tool


ISO 82304-2
Gaps & Roadmap

  • We predict whether your evidence meets the standard’s expectations for each criterion.
  • We provide a report that includes tailored advice for addressing any quality gaps.


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