Accelerate the Development, Registration, and Commercialization of Medical Devices by Achieving Validation Compliance with GO!FIVE® (6x faster)

 

Medical device companies are highly regulated and need to prove that their development, processes, and final product are consistent.

This is the role of validation and qualification.

But, do you know that compliance efforts can impact more than 30% of profits*?

30% of profits*

*Access the reference source by clicking here

The main challenges for small and medium companies:

  • Lack of a skilled validation workforce.
  • Takes time to train professionals.
  • Validation can delay product registration and production.
  • Organization of documents.
  • Adapt layout and configure documents.

Note.: improperly indexing test evidence can result in non-conformities.

 

 

How can we increase productivity, reduce costs, and optimize time if hiring another person isn't the solution?

The answer lies in GO!FIVE®, a digital validation software with integrated solutions designed for medical device teams. It simplifies submission processes and audit preparations while accelerating the time-to-market.

  • 6x more productive.
  • Different reviewers at the same deliverable.
  • Access several contents and libraries.
  • Automatic document formatting.
  • Off-the-shelf system.
  • Quick and free deployment.

 

It is built to include standard medical device frameworks, including:

  • Regulatory Agencies: FDA 21 CFR 820.30, FDA 21 CFR Part 11, EU MDR 2017/745, EU IVDR 2017/746
  • Quality Systems: ISO 13485:2016
  • Risk Management Process and Methods: ISO 14971:2019
  • Medical Software Development: IEC 62304:2006+AMD1:2015, AAMI TIR 45:2023 and ANSI/AAMI SW96:2
  • Human Factors and Usability Engineering: ANSI/AAMI HE75:2009, IEC 62366-1:2015

Click here to learn more about GO!FIVE®

Accelerate time-to-market, reducing validation and qualification time by 6x, streamlining compliance and at a lower cost!

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