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ColabON- Certify:  Agile Compliance for Digital Health

Who wants to review our agile digital health QMS as part of a peer review and have it certified as a QMS in 2024?

OVERCOMING THE HURDLES TO DIGITAL HEALTH PRODUCT APPROVAL

The approval of digital health products can be a challenge. Start-ups and established companies often encounter difficulties in formulating processes and requirements. This issue is complex and interdisciplinary, requiring new, agile, and systematic processes to ensure safety and effectiveness.

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Our Solution:

  • Integration of cybersecurity and data privacy

  • Radio frequency certification

  • Clinical expertise and

  • Regulatory expertise for seamless approvals

Verwendung von Glukometer zu Hause

DIGITAL HEALTH QMS  

ColabON Certify addresses the compliance needs of the following types of companies:

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  • Established companies that are entering the development of medical device software and are seeking agile processes to accelerate market approval and software updates.

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  • Startups in medical device software that need certification support.

DIGITAL HEALTH PRODUCT  TYPES

ColabON Certify caters to the compliance requirements of the following product types:

1. Stand-alone software (SAMD) being Medical Device or IVD with

  1. Algorithms

  2. Artificial Intelligence (AI)

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2. Cyber devices (FDA definition): Medical devices connected to the internet with technology vulnerable to cybersecurity threats

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3. Digital health software: This applies for example to devices without an intended medical purpose. Here is some more information, 

FASTER MARKET APPROVAL

ColabON Certify enables accelerated certification through:

  • Innovative agile process approaches in development and approval

  • Ready-to-use processes for digital health products

  • Legally licensed standards

  • Proposed product requirements, all developed by industry experts

Digital Health QMS compliance

BENEFITS OF COMPREHENSIVE SOLUTION

Eliminate development delays with:

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  • ColabON Certify offers the following benefits:

  • Faster market access

  • Improved traceability

  • Reduced validation risks

  • Efficient resource allocation​

THE BENEFITS OF COLABON CERTIFY

CONTACT

 

If you are interested in collaborating on our project for a new agile compliance system for digital health products, please contact us.

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