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.
Deliverables
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
$13,500 CAD
As we thrive for customer success, our reports & advice are tangible and practical.
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