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Focalcube det moderna ledningsystemet - Ett eQMS med dokumenthanteringssystem och ärendehanteringssystem

Your new
management
system

Focalcube is a digital system that streamlines your daily operations with smart solutions for the entire organization. An eQMS which is easy to use and customize — locally developed and delivered with expertise in certifications!

A complete and flexible solution

Quality management is collaboration — striving for the next level. Procedures and forms are no longer enough. A modern organization needs robust IT support. Something that can be set up in no time and provides all users with control and a clear overview.

Planning and control

Planning and control

For managers

Visualize your processes, manage your annual cycle, publish documents and news, plan your audits... Management is more enjoyable with the right tools!

More about quality assurance

Get the job done

For everyone

Focalcube gathers all tasks in one place. Tickets, meeting actions, project activities... all with convenient reminders and notifications.

Use the information in Focalcube to understand how your organization operates.

Follow-up

For those who want to dive deeper

Use the information in Focalcube to understand how your organization operates. Drive continuous improvement with visualization and data.

Integration av kvalitet, miljö, arbetsmiljö, social hållbarhet och informationssäkerhet

Unleash the power of your team

A modern, digital management system often integrates quality, environmental sustainability, social responsibility, information security, and other industry-specific aspects.

Many organizations also require certifications such as ISO 9001, ISO 14001, and ISO 27001.

Focalcube is an ecosystem designed to manage and maximize the value of all these governance areas. It's time to focus on structure, collaboration, communication, visibility, and continuous improvements!

Webinars

Here you can find the webinars conducted by Medos in collaboration with GBA Key2Compliance AB.

CAPA

In this webinar, we explore how medical device manufacturers can manage a CAPA, i.e., corrective and preventive actions. We cover the requirements from MDR, FDA, and ISO 13485 and provide a practical example of how it can be documented and managed using Focalcube.

Change management

In this webinar, we discuss what to consider when implementing a change to your medical device product. We cover the requirements from MDR, FDA, and ISO 13485 and provide a practical example of how Focalcube can be used to document the change in a way that meets the requirements.

Lots to do?

Make things happen with actions!

Use actions wherever you need them — in connection with meetings, projects, tickets, and more. It’s always easy to create an action and get things done. Each action has an owner, a description, and a deadline. Naturally, Focalcube sends reminders, leaving no doubt about who needs to do what and when. Now you have full control over what needs to be done!

New product database

We’re expanding Focalcube’s product database with a range of powerful features!

With Focalcube’s new product database, you’ll be able to manage complex product structures and handle versions of products and sub-products. It also allows you to define release checklists. You can easily get an overview of all materials that make up the product, as well as the markets where the product is available. Additionally, you can list the suppliers used and much more.

Did you miss the last service?

Gather all information about your assets in one place.

Gain a clear overview and clarify who is responsible for what. In Focalcube, you can create your inventory list for equipment, facilities, machines, or instruments—regardless of their physical location. Based on predefined intervals, Focalcube reminds you about tasks such as servicing, calibration, or sampling. The reminder reaches you as the deadline approaches. Never miss a service again!

Is the auditor happy?

Are you ready for the external audit?

It's easy to feel nervous before a certification audit, but with Focalcube, you can quickly find everything the auditor asks for. Everything is gathered in one place, and all the answers are in Focalcube — nothing else is needed. But if you get an especially tricky question and need a lifeline, our global search function is always there to help. That way, you'll survive the audit, and the auditor will leave satisfied!

Focalcube support is here for you

If you have a question, if something isn’t working as expected, or if you need assistance, we’re always just a phone call away. Our support team is happy to help you with anything you need. Support is available by phone between 8:00 AM and 4:00 PM at +46 (0)13-14 00 55. You can also reach us via email at This email address is being protected from spambots. You need JavaScript enabled to view it.. Talk soon!

Efficient issue handing?

Different issues require different workflows.

With Focalcube's ticket management, you can configure your own workflows to align perfectly with your processes. Create different ticket types with unique workflows. This way, you can streamline your ticket management, reduce handling times, and achieve higher customer satisfaction. All this with Focalcube!

How do you train your employees?

Do you have insight into your employees' competencies?

With Focalcube, you can track who has completed relevant training modules. Using the built-in "read and understood" feature, documents can be distributed to the appropriate employees. Monitor employee competencies with Focalcube’s questionnaires to ensure training efforts have been effective. All results are automatically saved in each person’s training log. Document competencies more easily with Focalcube!

Which of your suppliers are approved?

With Focalcube, you can easily manage and monitor your suppliers and distributors.

The responsible person receives reminders when it’s time to update agreements, conduct supplier evaluations, or perform audits. All contact details, documents, and reports are stored, and the list provides a clear overview of their category and whether they are approved or not. It doesn’t get any smoother than this!

What does the process say?

Struggling to keep track of all processes?

With Focalcube, everyone can easily access the current processes in your management system. Finding and reviewing them is quick and simple. You can also access the templates and instructions you need. As a process owner, you can design workflows, document, and release your processes. Training everyone is effortless with the "read and understood" feature. Rest assured — everyone knows what to do!

Is your data secure?

Are you hesitant about storing sensitive information in the cloud?

You can feel confident with Focalcube, which is continuously developed with new security features. Focalcube provides strong encryption of data both at rest and in transit, automatic backups, audit trails and automatic security notifications, multi-factor authentication, enforced strong passwords, comprehensive logging and monitoring, access control with permission groups and GDPR compliance.