QAiRA for Quality Management
The new European Union Medical Device Regulation (MDR) will introduce several new requirements for health tech organisations and further specify previously issued ones. QAiRA is a software developed by Kasve for managing these regulations and carrying out quality management. The service was created to make the work of quality managers, persons in charge of regulatory issues and product managers run more smoothly and to promote faster market entry of products.
The service was launched at the turn of the year 2020–2021 and it is currently already used by over 50 health tech manufacturers, contract manufacturers and distributor organisations.
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.
- Cover all European medical device standards with harmonizations to European legislation with the help of QAiRA.
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 Tools
- 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.
Up-to-date quality management!
QAIRA was created to make the work of quality managers, persons in charge of regulatory issues and product managers run more smoothly. Interested? Book a demo today!
Quality management made easy
QAiRA contains information about over four thousand (4,000) key regulations, standards and instructions, which you can manage using a simple search feature. The service enables you to follow the provisions relevant to your product and organisation to ensure compliance with valid legislation. The system alerts you of possible coming changes, new versions or harmonization.
We have created easy-to-use tools based on the most essential standards and requirements so that you can easily make sure you fulfil all relevant requirements and follow the progress of your projects.
User-friendly toolkit
The service currently includes various tools and checklists for determining your product compliance, manufacture and auditing your quality system. We constantly develop new tools based on user feedback.
Use the user-friendly on-boarding wizard to determine what requirements apply to your product and which standards and guidelines are related to the requirements. With our service, it takes barely any time for you to get access to a General Safety and Performance Requirements checklist, which also serves as an excellent project tool towards complying with the requirements.
The service also includes an integrated news feature that allows you to follow key industry news sources from around the world and get an email summary of them.
QAiRA is compatible with all cloud-based documentation management systems.