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An eQMS for medical device operations

Focalcube for medical device companies

Solutions for medical device companies and organizations that manage or use medical devices.

Focalcube is developed and operated by Medos AB. We are specialists in quality management and regulatory affairs for medical devices. Focalcube has been designed to provide optimal support for those who want to leverage and certify against ISO 13485.

Make ISO 13485 more enjoyable and easier!

Focalcube has been developed to simplify working with ISO 13485. The system includes modules for all parts of the standard - everything from management and planning to follow-up is made easier with Focalcube.

When it’s time for a certification audit, it’s easy to identify what needs to be addressed, and all information is gathered in one place - organized and structured!

Visual processes

With Focalcube Processes, you can draw your own process diagrams, describe your processes, publish documentation, and manage tickets in a natural and clear way.

Powerful document management

Focalcube allows you to manage your documents directly in the cloud. Access control, version management, electronic signatures, full-text search, automated numbering, metadata linking, and much more ensure your documentation is in order.

Electronic signatures and traceability

All important decisions are signed electronically, and audit trails are maintained automatically. Everything can be traced afterward.

Continuous improvements - for real!

Focalcube makes ticket management accessible to everyone. Issues and changes can be raised and prioritized directly - nothing is forgotten. As a quality manager, you can easily search for information and analyze trends. The system provides entirely new possibilities to identify problem areas, which is a key factor in anchoring improvement projects.

Track competence

With Focalcube Training, it’s simple to arrange training sessions and follow up with knowledge tests. Naturally, it integrates with the system’s "read-and-understood" feature.

Organize assets

Focalcube Assets keeps all types of assets organized, such as machines, measuring instruments, IT systems, and delivered systems. Calibration schedules, service reports, and much more are made easier.

A system for all tickets

Focalcube allows you to handle all types of tickets in the cloud, such as customer complaints, returns, change orders, internal process deviations, and environmental deviations. You can configure the system yourself to organize it as needed. Assign ticket owners so that nothing falls through the cracks. All tickets in one place - structured and organized!

Use Focalcube’s ticket module as a general ticket management system, deviation management system, claims system, or customer support/helpdesk system.

Everyone can participate

Focalcube makes it easy for everyone to contribute information - even external partners, customers, and suppliers. Advanced features for subscriptions, comment threads, and a personal to-do list make it easy for everyone to understand what is expected of them.

Koll på dokument och flöden i sveriges vassaste eQMS

Control your documents and workflows

Focalcube Documents makes it easy to manage and oversee all document workflows. Electronic signatures, distribution at group and role levels, and logging of who has read and understood are key features for modern document management.

A selection of QMS features

Document the management system's processes

Focalcube Processes can be used to visualize and describe processes. Focalcube Documents is used for all types of governing documentation.

Focalcube Processes
Follow-up

Focalcube offers a variety of tools for tracking both individual tickets and details, as well as overarching goals and outcomes.

Focalcube Follow-up
Manage and track changes

Focalcube Tickets serves as the hub for all types of changes. Workflows and information processing are configurable. Lists and search capabilities provide a clear overview and support continuous improvement.

Focalcube Tickets
Management of outsourced processes

As a customer, you can have multiple databases in Focalcube, allowing you to manage supplier-related processes and tickets separately from your internal management. This provides you with unparalleled control over your outsourced processes.

Focalcube Tickets
System validation

Focalcube can be delivered pre-configured for validation, with ready-made templates for validation within your organization. Focalcube Assets can be used to manage intervals and gather documentation from the validation of all your other systems.

Focalcube Assets
Management of technical documentation

Your technical documentation can be consolidated in one place with Focalcube Documents. The module supports features such as electronic signing, distribution, and reminders for planned updates. Drawings and other materials can be directly linked to relevant items in Focalcube Products.

Focalcube Documents
Documents and records

Focalcube Documents, together with Focalcube Processes, is naturally suited for all governing documentation.

Documents are signed electronically and distributed to relevant individuals for "read-and-understood" confirmation.

Other modules, such as Focalcube Tickets, Focalcube Meetings, and Focalcube Training, seamlessly manage large parts of your reporting documentation.

Focalcube Documents
Management review and other meetings

Management reviews are easiest to plan by defining a meeting type in Focalcube Meetings. The meeting is planned according to the standard’s requirements and then documented directly in Focalcube. The meeting notes are finalized directly in the system. Decisions are recorded as actions with assigned owners and deadlines. Focalcube ensures follow-through with reminders.

Focalcube Meetings
Training and competency follow-up

Training sessions are planned and documented in Focalcube Training. After completing a training session, participants take a knowledge test. The results are recorded in the participant’s personal competency list, along with information about documents that have been read and understood.

Focalcube Training
Infrastructure and assets

All types of assets, such as machines, computers, measuring instruments, IT systems, and delivered systems, are managed in Focalcube Assets. For assets requiring validation or calibration, automated schedules are created that generate timely reminders. Service reports are, of course, handled directly in Focalcube.

Focalcube Assets
Purchasing and release to inventory

Focalcube Products is used to set up the entire product structure. Supporting materials are directly linked to Focalcube Documents. The ERP system can be integrated with Focalcube Products to provide access to production documentation when purchase orders are sent.

Release checklists are defined at both the product type and product level to streamline the release process to inventory.

Focalcube Products
Handling non-conformities and CAPA

Deviations, corrective actions, and preventive actions are documented in Focalcube Tickets. You define your workflows and decide what information to collect for each ticket type. Actions are documented and tracked directly in Focalcube. Suppliers and partners can be invited to participate in the process.

Focalcube Tickets
Helpresk and complaints

Focalcube Tickets integrates with Focalcube Inbox. Your customers email your support address, and the messages are displayed directly in Focalcube. The entire support team works from the same task list. Tickets are easily created based on incoming emails. Customer communication takes place directly in Focalcube with full traceability. Naturally, you control at the ticket type level what information to collect and which workflows you prefer.

Focalcube Audits
Access control
Access control

Users can easily be divided into groups to restrict access to items. Powerful configuration options make the work straightforward and transparent for those responsible for the management system. Access control in advanced modules, such as Focalcube Products, is naturally based on the information hierarchy that is established.

Comments
Comments

Each ticket includes a separate discussion thread, making it easy for colleagues, partners, and suppliers to comment ongoing matters.

Document management
Document management

For each ticket, you can upload and version-control attachments. Images, documents, and other supporting documentation are stored where they belong – within the ticket.

Easily separate and find documents
Easily separate and find documents

With Focalcube, you can easily create separate document collections for your files, making it simple to keep documents organized. Within a document collection, you can create a folder structure and specify metadata that can be used for filtering and searching. In addition to these flexible structural options, Focalcube also provides access to fast and powerful full-text search within documents.

Export of tickets
Export of tickets

A ticket can easily be exported to Word format based on your custom document template. The ticket list can also be effortlessly exported to Excel for analysis and summaries.

Flexible document numbering
Flexible document numbering

A common challenge in document management is handling document numbering. Many companies use an Excel sheet to track document numbers, often facing daily frustration when two documents accidentally receive the same number.

With Focalcube, you can decide per document type whether you want fully automatic or manual document numbering. For manual numbering, the system assists you in selecting an available document number. For automatic numbering, you can set up custom rules for prefixes and numbering.

Using smart document tags, document properties such as document numbers and revision numbers can be automatically inserted into the document header or footer.

Follow-up
Follow-up

Focalcube provides quick access to graphical summaries of, for example, tickets. Analyze the information from different angles to improve your operations based on trends and problem areas. You can also create automated KPIs in Focalcube Follow-Up.

Fulfils ISO requirements
Fulfils ISO requirements

Many of our customers are ISO-certified in quality and environmental management. Focalcube offers features that significantly simplify the certification process.

Full text search
Full text search

All objects in Focalcube are indexed by an advanced search engine, making it easy to find exactly the information you need.

Full traceability
Full traceability

All changes are logged with a complete history. The history enables restoring information and tracking changes during audits and inspections.

Focalcube naturally keeps track of all old document revisions. As an administrator, you can also prevent your users from accessing outdated revisions.

Integrated with other modules
Integrated with other modules

Tickets are a central part of Focalcube's other modules. Customer complaints, supplier issues, service tickets, and audit deviations are directly linked to their respective modules where they belong.

Metadata in header and footer
Metadata in header and footer

All metadata that can be specified for a document — such as document number, revision number, title, author, and validity date — can easily be inserted into the document as tags. These tags can be placed in headers, footers, and within the document itself, and they are automatically kept up to date by Focalcube. This tagging works equally well in Word, Excel, and PowerPoint as it does in Focalcube's own online documents.

One place for publishing
One place for publishing

Many lack a natural place to publish their documents. Often, they are stored in a folder on a file server where they are hard to find, with current versions mixed up with old drafts. With Focalcube, you get a dedicated space where your documents naturally belong, integrated with the other Focalcube modules you use daily.

Focalcube also helps you keep the valid published version of a document linked to its drafts, eliminating the need to manage drafts separately.

Portal for partners
Portal for partners

External parties can be invited to their own workspace, where they can continuously create tickets, participate in comment threads, and upload related information.

Powerful lists
Powerful lists

All lists are easy to overview and configure. Free-text search and advanced filters make it easy to find the right item. It's also simple to prepare a list of items to go through during, for example, a meeting. Additionally, all lists can easily be exported to Excel or PDF.

Quick preview
Quick preview

Focalcube naturally offers a preview view for Microsoft Office files (Word, PowerPoint, Excel), PDF files, text files, and image files. This allows all employees to read documents without needing to download them to their computers.

Reminders
Reminders

When ownership of an item is assigned to an employee, an automatic notification is sent. Ongoing reminders are issued for key events – for example, when a supplier needs to be evaluated, an external audit is approaching, a KPI value needs to be reported, or when a ticket changes status.

Smart linking
Smart linking

Focalcube's other modules are closely integrated with Focalcube Documents. This allows you to link, for example, a ticket or a meeting to a document. The documen — whose access is primarily controlled by the document collection's access settings — then also becomes available to users who have access to the linked objects.

Subscriptions
Subscriptions

Each user can configure their own subscriptions. When new tickets are created, notifications are sent to the relevant users. Naturally, owners and other stakeholders are informed when tickets are updated.

Team inbox
Team inbox

Focalcube can be connected to the team's inbox for incoming support. Incoming messages can easily be converted into new tickets. Ongoing email communication with the customer is managed directly from the ticket. Each employee can set up a personal email signature.

To-do list
To-do list

Too many tasks coming from all directions? Struggling to keep track of priorities? In Focalcube, all activities are gathered into a unified personal To-Do list. The system prompts you with reminders and helps you prioritize.

Valid electronic signatures
Valid electronic signatures

Focalcube is fully integrated with Assently, enabling you to send a document for signing to both internal and external users. Signing via Assently provides a valid signature that can be externally validated. The signature is added to the signed PDF document. For signing, Mobile BankID, SMS, and touchscreen signing can be used.

Work in multiple time zones
Work in multiple time zones

Users can easily set their time zone. All timestamps in the system are automatically adjusted to the personal time zone.