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Comprehensive Online Toolkit for Medical Device Regulatory Management

Key Features

My regulations

  • Choose legislations, standards and guidance, significant to your company and your product
  • Let QAiRA keep you up-to-date in the upcoming regulatory changes.
  • QAiRA covers all European medical device standards (both published and in work programme) with harmonizations to European legislation.

My feeds

  • My Feeds gathers the current topics about medical device´s standards and regulations and compiles them to a single, easy-to-follow stream.
  • You can customize the view based on your product and the market.
  • You can also choose which feeds give you an email notification upon updated.

My Toolkit

  • My Toolkit contains the essential, easy-to use tools needed to ensure the regulatory compliance of your products and quality management system.
  • Tools of My Toolkit can be linked to quality management system documents and technical documents creating a structured, comprehensive big picture.
  • Examples of tools in My Toolkit; GSPR checklist tool, Risk management tool (ISO 14971), clinical evaluation tool, instructions of use tool, etc.

The QAiRA story

QAiRA service is developed and maintained by Kasve medical device and software professionals.

The service was created out of organic need to follow regulatory requirements digitally and automatically. This is crucial from Medical Device Regulation (MDR) viewpoint, because medical device manufacturer needs to follow and show evidence that applicable regulations and standards are followed.

The service is currently in piloting phase and target for release is in early autumn 2020.

Digital QAiRA solution helps medical device manufacturers to manage and track their own product regulations and standards effectively and keeps them updated.

Qaira Team

Elias Haapakorva

Elias Haapakorva

Chairman of the Board
elias.haapakorva [at]
+358 40 183 1214

Jani Hopia

Jani Hopia

Senior Regulatory Affairs Specialist
jani.hopia [at]
+358 400 790 074

Ville Helenius

Ville Helenius

Chief Operating Officer
ville.helenius [at]
+358 50 470 8115

Lauri Heinonen

Lauri Heinonen

Software Developer
lauri.heinonen [at]

Contact us