Is your organization ready for MDR?

Secure routines around medical devices create safety for both patients and staff. With the right support, MDR doesn't become a burden – but an opportunity to improve quality in your organization.

Why MDR concerns you as unit head

Medical devices are a natural part of healthcare – but they also involve responsibility. As unit head, you bear ultimate responsibility for ensuring your organization follows both the EU's Medical Device Regulation (MDR, EU 2017/745) and the National Board of Health and Welfare's regulations HSLF-FS 2021:52.

It's not just about law. It's about patient safety, work environment – and your peace of mind as manager.

What do the regulations require?

MDR (EU)

Sets requirements that medical devices are safe, effective and traceable.

HSLF-FS 2021:52 (Sweden)

Specifies the healthcare provider's responsibility: routines, training, documentation, traceability and reporting.

If you fail with compliance, you risk both patient safety and the authorities' trust.

Your biggest challenges

Excel lists and binders quickly become outdated.

Staff lack smooth access to user manuals and information.

Difficult to know where products are and what condition they're in.

Incident reporting risks being delayed or lost.

In short: manual systems are no longer sufficient.

Why unit heads choose Alisa

Alisa is developed to make compliance simple.

Traceability

Full control over products, costs, expiration dates and service history – via QR codes and digital inventory lists.

Accessibility

User manuals and important documentation collected in the app – always close at hand for staff.

Speed

Functional checks, service and events are documented directly on-site – allowing licensed personnel to spend more time on care instead of administration.

The result?

Secure compliance, fewer risks and more time for care.

Act proactively today

MDR and the National Board of Health and Welfare's regulations are not optional. As unit head, you are obligated to follow them – but you can choose how.

With Alisa, you get a system that makes regulations easy to follow, while freeing up time for what matters most: good and safe care for patients and users. Contact us today to see how we can strengthen your organization.