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ACTIV for ISO 13485: 2016

A full ISO 13485: 2016 system requires many different procedures and record types to be compliant, all of which require maintenance with surrounding change control, review and approval processes. The labour-intensive nature of such a system leaves strains on time and resources for any company aiming to remain fully compliant.

Here at Advena we offer a fully equipped electronic quality management system package named ACTIV which aims at providing a reliable, burden free methodology for maintaining a Quality Management System.

The modules within ACTIV organise, control and help implement all the necessary areas of the Quality Management System as well as internal projects eliminating added risk from your system, modules include:

  • Audit Manager
  • Processes
  • File Manager
  • Improvement Log
  • Business Risk Manager
  • Legal Compliance Manager
  • Incident Log
  • Customer and Supplier Manager
  • HR Manager
  • Asset Manager
  • Teams
  • Forums

ACTIV gives you a framework in which you can store, track and control your processes and documents. ACTIV’s automated workflows prompt you to record and maintain information, ensuring you comply with ISO standards and legislation. ACTIV provides you the tools to assign actions and manage change. Its features continually evolve to match updated standards. ACTIV can be validated on implementation to ensure continued results.

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