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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.

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:

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

  • 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)

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

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:

  • 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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