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QMS Design

Rook’s team of quality engineers will create a custom QMS for your company that is both efficient and easy to maintain for your product and scope. Our systems are audit ready, and continually updated to ensure compliance with effective regulations.

We have custom QMS templates that will provide a clear path for you to create your device and maintain compliance.  These templates are customized for each company to ensure they meet the needs and size of the company.  Our templates are audit proven and can be implemented in your QMS in as quick as a few weeks.  We have specific templates for all types of devices including the following

  • SaMD Products including Agile Practices and devices with AI/ML
  • Diagnostic templates specific for building and maintaining IVD products
  • Electrical products meeting requirements for IEC 60601
  • Templates for implantable and sterile devices including Class III products. 

Rook’s team has experience customizing QMS templates for international regulations, including CE Mark under MDR, MDSAP, TGA, ANVISA, and other markets. 

Our QMS templates are designed to take a clear approach to the regulations and focus on efficiency and simplicity.  There is no need to over complicate the QMS especially with a small team.  RookQS templates allow our clients to reduce the documentation burden and complexity while maintaining high quality and compliance. 

In addition to creating your QMS, RookQS quality engineers can also maintain your QMS as a contract quality team; this includes yearly audit packages, management review, complaint handling, CAPA, and non-conformance management.  We provide a full service QMS management team for small to large size companies managing your quality system as a service. Let Rook’s team grow and develop your QMS as your company grows!

Related Resources

Align Agile Practices with QMS Requirements

By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project management. With the rise of the internet of things…

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Preparing your QMS for EU MDR

This webinar was hosted by Kyle Rose, President of Rook Quality Systems. You will find this webinar helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the…

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The Essential Guide to Preparing Your QMS For EU MDR

You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. Link to the Article: https://www.greenlight.guru/blog/qms-eu-mdr…

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