ISO 82304-2 Assessment

We help you reach new markets by simplifying the ISO 82304-2 process

We help you save time and energy by defining a strategic plan to build a better product, using the ISO 82304-2 framework as a powerful tool to meet the requirements of healthcare organizations.

Start with 1h FREE consultation

Get a detailed analysis of your software's compliance with advanced criteria, providing valuable insights to fulfill the requirements.

About ISO 82304-2

ISO 82304-2 supports healthcare authorities and providers in their review, procurement, or even reimbursement decisions for digital health apps solutions.

This framework assess 67 criteria, divided in 4 major quality indicators:
Healthy and safe, Easy to use, Secure data and Robust built.

High-end compliance implies high risk? No.

We reduce your risk by providing knowledge of healthcare organizations' needs and decision-making processes.

We save you time with pre-mapped milestones to support execution without having to going deep down the details yourself.


1-2 months

Gap Assessment Report

  • Identification of gaps and areas for improvement to your product for each major quality indicator.
  • ISO 82304-2 topics: healthy and safe, easy to use, secure data, robust built.

Advice & Priority Planning

  • Advice & insights for each quality indicator.
  • Structured milestones including actionable steps.
  • Prioritization levels for each milestone to support roadmap planning.

Co-Pilot Package

  • Dedicated human support for personalized assistance in navigating milestones and quality indicators.
  • Access valuable resources to support the execution of your compliance plan.

ISO 82304-2 Assessment


As we thrive for customer success, our reports & advice are tangible and practical.


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