Yes, Samedis.care enables you and your facility to meet all required provisions of the Medical Device Operator Ordinance (MPBetreibV). We provide you with a comprehensive solution that allows you to meet legal requirements regarding the operation, use, and maintenance of medical devices in a legally compliant manner.

With Samedis.care, you can in your facility:

• Document training in the proper handling of medical devices.
• Designate a medical device safety officer and perform his or her functions in accordance with legal requirements.
• Plan and carry out regular maintenance measures to ensure the safe and proper operation of medical devices.
• Keep an inventory of all medical devices and document important information such as name, serial number, and responsible persons.
• Carry out the reprocessing of medical devices taking into account the manufacturer’s specifications and ensure the success of these procedures in a traceable manner.
• Plan and carry out metrological and safety technical inspections in accordance with the provisions of the MPBetreibV.
• Keep comprehensive medical device documentation that contains all relevant information about the medical devices and is accessible during working hours.

All data for your facility is stored encrypted in certified and state-of-the-art data centers in Germany.

Only you and the people you actively authorize have access to your data.

Furthermore, we are ISO 27001 certified, which means we meet strict security standards and processes in addition to GDPR.

More information about the security and confidentiality of your data.

Samedis Care is for the facility — My Samedis Care is your personal digital device passport.

In Samedis Care, medical device officers manage inventories, training, and maintenance for the entire facility. My Samedis Care is your personal area: There you can see your used devices, your training status, and your complete training history — across facilities. Everyone who has a login automatically gets a My Samedis Care account. When you change employers, you simply take your digital device passport with you.

my.samedis.care is the free platform for all users of medical technology devices.

Save time and connect with your healthcare facility thanks to an easy to use, mobile and desktop app designed for your professional work. Maintain your digital device passport and share your training with your healthcare facilities, whether you’re at your desk or on the go. my.samedis.care simplifies your everyday life by giving you access to relevant and up-to-date instructions for use, application guidance, and safety information.

What features are available in my.samedis.care?

• Digital device passport: Secure your certificates independently of your employer. Every device training is documented directly in your personal account.
• Easy sharing of training: Reduce the number of duplicate trainings by sharing your received training directly with your connected healthcare facility.
• Voice & video support for devices: Create a text, voice, image, or video message request about a device within your facility and automatically reach the right contact person.
• Access to device information: Always have access to the relevant and up-to-date instructions for use, application guidance, and safety information.

No. Samedis Care is a pure web application — you only need a browser.

On Android use Chrome, on iPhone use Safari. No data is stored locally on your device. Photos or videos you take, for example for a malfunction report, are uploaded directly encrypted to the server — not in your photo gallery. The only app that can optionally be installed is the QR code print app for label printers (Brother P-touch or Epson Labelworks).

From a technical standpoint, yes — you only use the encrypted web browser.

Since no data is stored locally and everything runs over an encrypted connection, the use of personal devices (Bring Your Own Device) is unproblematic from Samedis’ perspective. Whether your facility allows this organizationally, please clarify internally with your data protection officer or IT department.

Yes — Samedis Care is currently available in German, English, French, Dutch, and Russian.

You can change the language in your account settings. Additional languages will be added in the future.

The bell shows you new notifications — such as pending approvals or system updates.

When a number is displayed, you have unread messages. Click on it to see the details. If you don’t read a notification within a few minutes, you’ll receive an additional email so nothing gets lost. Update announcements are also distributed via the bell, but are not sent by email.

The application administrator is your internal contact person for access rights and configuration.

Samedis Care has no access to your facility data unless we are explicitly invited. For permission changes, employee setup, or configuration questions, contact your application administrator. Tip: Create the position “Application Administrator” under Facility > Positions and assign the person — then they will be visible to everyone in the directory.

Yes — you can give him user access, and he can then access your device inventory.

The service provider can then upload inspection reports, document repairs, and process actions — directly in the system. Alternatively, you can send malfunction reports with photos and videos to him via the request system, which he will receive by email.

Yes — Return = Yes/Confirm, Escape = No/Cancel.

This applies to all confirmation dialogs in Samedis Care. Particularly useful if you want to remove multiple entries in succession: Click on X, press Return — much faster than moving the mouse to “Yes” each time.

You can log in to Samedis Care via the browser — no app installation required.

Open app.samedis.care in your browser or click “Login” on the website. You can sign in with your email address and password or alternatively via Microsoft 365 or Google Single Sign-On. Samedis Care works on any device with an internet connection — smartphone, tablet, or desktop PC. The interface automatically adapts to the respective screen size.

To use my.samedis.care, simply open the website https://my.samedis.care on your smartphone, tablet, or desktop PC. Register using your email address and create a free account.

If you already use Samedis.care in your facility, you can log in to my.samedis.care with the same user account and do not need to register again. Conversely, of course, with your account that you use for my.samedis.care you can also log in to app.samedis.care in facilities if you have other tasks there (for example as a medical device officer).

No. You can reset your password yourself.

Click “Forgot password” on the login page and follow the instructions in your email. Samedis Care is an external cloud service — your internal IT is not responsible for it. Optionally, you can set a recovery email address in your account settings (e.g., your personal address) so you can access your account even after changing employers.

You can enable multi-factor authentication (MFA).

In your account settings, you can set up an authenticator app (e.g., Google Authenticator). Then, in addition to your password, you will need a 6-digit code that is generated anew every 60 seconds. This is optional, but recommended.

Your account will be locked for security reasons — you can unlock it by email immediately.

You will automatically receive an email with a link to unlock it. If you did not cause the lock (e.g., by accidentally pressing the caps lock key), please inform your IT or Samedis so we can check where the login attempts came from.

Yes — with a single login you can access all facilities where you are authorized.

You can switch between your tenants (facilities) at the top of the navigation. This is particularly convenient if you work at multiple locations. You can even share your training between facilities via My Samedis Care.

Go to Device Data > New and follow the wizard.

In the first step, search for the device type in the catalog. If you find it, select it. If not, click “Continue without device type” — our content team will create the catalog entry for you in the background. Required fields are: inventory number, serial number, year of manufacture, and device location. Important: Always photograph the device label and upload it — we can reliably create the catalog entry from it.

An inventory is the individual physical device — the device type is the product category in the catalog.

For example, if you have three identical infusion pumps, these are three inventories, but one device type. Training is documented at the device type level: whoever is trained on the type is trained on all inventories of that type.

Yes — via custom device types.

Under Facility > Custom Device Types you can create any products (e.g., computers, printers, displays). These appear in your local catalog and can be inventoried like medical devices. Important: For these devices, set the checkbox “Not a medical technology device” under Advanced so they do not appear in the official inventory list.

A central catalog of all medical devices that Samedis Care maintains for all facilities.

Here you will find device types with detailed information, instructions for use, manufacturer specifications, and regulatory data. The data comes from various sources: community contributions (from facilities and service providers) and directly from manufacturers. In the future, there will be a button to submit change suggestions directly from the interface. You can use a switch to filter whether only devices from your inventory or all catalog entries are displayed.

Create inventory anyway with “Continue without device type” — we will create the catalog entry for you.

If you upload the device label and fill in the basic information (device type, product name, manufacturer), our content team will create the device type in the background. You don’t need to do anything else. For software medical devices (e.g., digital medication), the same procedure applies: report the type with manufacturer, exact product name, and software version.

The QR code is your quick access to all information and actions related to the device.

Scan the QR code with any smartphone and you will land on a landing page with: instructions for use, your personal training status, the option to request or document training (ad-hoc training), a malfunction reporting function, the medical device documentation, and the next inspection date.

You can edit multiple devices at once — e.g., department, location, or operating status.

Select multiple inventories using checkboxes and click “Multiple Change”. Typical use cases: moving devices (new location), decommissioning multiple devices, or assigning a service partner.

Under the technical data of the inventory, you can enter the software/firmware version.

This is especially important for Annex 1 products: if the manufacturer installs a firmware update and a new training is required as a result, you need to be able to recognize that. Ask your service provider or manufacturer after each software update: “Is new training required?”

Device systems combine a main device with its additional modules.

Example: A Da Vinci robot with additional devices. When you assign an additional device to the main device in the inventory (“belongs to”), you can select the device system during training — then all additional devices will automatically be included in the training.

Annex 1 = critical devices with high application risk, Annex 2 = lower risk.

For Annex 1 products (e.g., ventilators, anesthesia machines, lasers), the initial training must be conducted by the manufacturer. Subsequent trainings may only be conducted by persons who have manufacturer training. For Annex 2 products, any trained user can train other users (snowball principle). Self-explanatory devices (without instructions for use) do not require documented training — but be careful: as of February 2025, once instructions for use exist, the device is no longer considered self-explanatory.

The application risk specification from the catalog can be overridden in the facility. To do this, open the device in the device catalog, click on Risk Assessment under More, and select the appropriate application risk – for example self-explanatory. This action requires the Manage Application Risk right in access management. Typically, the medical device safety officer performs this change. Special training is not required for this.

Tutorial: Define application risk for a device type

Three main forms: manufacturer training, user training, and ad-hoc training.

• Manufacturer Training: The manufacturer or their representative provides training — required for Annex 1 products (critical devices). You enter the external trainer manually with name and company.
• User Training: A trained colleague trains other colleagues. For Annex 1 products, only someone with manufacturer training may conduct user training.
• Ad-hoc Training: Directly at the device via QR code — quick documentation of spontaneous user training, must be approved by the medical device officer afterwards.

Under Training > New — a wizard will guide you through three steps.

1. Select Devices: From your inventory, from device groups, or from the global catalog (for loaner/demo devices).
2. Select Employees: From the employee list, from groups/departments, or create new ad hoc.
3. Determine Trainer and Type: User or manufacturer training, set date, sign digitally or use paper form.

Digital is faster, more secure, and recommended.

With the digital version, everyone signs directly on tablet or smartphone — the training is immediately recorded and employees without signatures are automatically removed (no “forgotten signature” problem). The paper version creates a PDF for printing. After training, the signed form must be brought back into the system (scan or photograph with smartphone camera via QR code on the form).

The employee is automatically removed from the training.

When you finish and a signature is missing, the system will warn you. If you proceed, the unsigned participant will be automatically removed. The training is only recorded for those who actually signed.

No — since the last update it is technically no longer possible to select yourself as a trainer.

Persons who are on the participant list cannot be selected as the trainer at the same time. This applies to both user and manufacturer training.

The system shows you when the selected trainer does not have documented qualifications for certain devices.

For example, if you have selected three devices and the trainer can only provide manufacturer training for one of them, it will explicitly show which devices are affected. You can still proceed — the responsibility lies with you as the medical device officer. Tip: Use the “Show only qualified trainers” switch in the selection dialog.

According to current law: No — a video alone does not replace training by a physical person.

Videos can be used in a supporting capacity (e.g., as learning material attached to the device type), but according to the Medical Device Operator Ordinance, training must always be conducted by a person who can answer questions. You can link manufacturer videos as content on the device type, but you must still document a trainer.

Create training, set the date to the past, activate “Paper form” and upload the proof.

Select devices and employees, enter the original training date and activate “Conduct with paper form”. In the next step you can upload the existing document as proof — fastest by photographing it directly with a smartphone. You can also attach multiple proof documents to one process.

A run sheet is a form of training for a single employee with many devices — each with different trainers and dates.

Typical use case: A new employee joins the ward and needs to be trained on 10+ devices, which happens over several days. The run sheet can be printed as paper or completed digitally via My Samedis Care. With the digital version, the employee can see their run sheet in My Samedis Care, documents the individual trainings one by one, and completes it — then it goes to the medical device officer for approval.

The training remains as a record, but all statistics and proofs are reset.

The record is documented with status “invalid” and your reason — so it does not disappear, but no longer counts in overviews and proofs. The right to mark training as invalid can be restricted via access management.

Scan QR code on device > “Document training” > enter name and employee number > both sign > done.

Ad-hoc training is intended for spontaneous user training directly at the device. After saving, it goes to the medical device officer for approval. Only after their confirmation is the training officially documented and appears in statistics. The medical device officer can also reject the training.

Only employees who are documented as trained AND have agreed in My Samedis Care to be visible as trainers.

This is for data protection: an employee must explicitly enable the switches “Provides device training” and “Available” in My Samedis Care. Only then will they appear in the selection list on the landing page. As a medical device officer, of course you can always see all training status internally in Samedis Care.

Your personal task lists — you organize devices and employees for your area of responsibility with them.

You can create as many groups as you want and name them freely — e.g., “Anesthesia Devices”, “Monday Training”, “New Employees Q1”, “Intensive Care Physicians”. Each group contains devices and/or employees. Groups serve as filters in all overviews and as the basis for the training matrix. Recommendation: Create combination groups (employees + devices), then you have direct access to the matrix.

The matrix shows at a glance who is trained on which device — and where gaps exist.

Select your group and open the matrix. Green = training present (user or manufacturer), Red = training missing, X = device not in use. Click on an entry to jump directly to training documentation. Tip: Use the “Show only missing training” filter to focus on open gaps. You can create new training directly from the matrix — the missing devices and employees will be automatically pre-selected.

Each symbol has a clear meaning — the legend can be found at the bottom right of the matrix.

• Green (checkmark): User training present
• Dark green: Manufacturer training present
• Red (exclamation mark): Training missing — action required
• X: Employee does not use the device (marked manually)
• Minus (–): Employee is not assigned to this device in any training group
• Yellow question mark: Contradiction — marked as “not in use” in one group, but assigned in another group
• “Not assigned”: In the cross-group matrix — employee is not assigned to this device in any group

Yes — in the employee overview and in the trainer selection dialog.

In the employee overview you can show the “Training Type” column and filter by “trained by manufacturer”. This is a quick way to find out who is qualified to be a trainer for a particular device. You can also export the result to Excel.

In the matrix overview: Click the magnifying glass and search for the device type or employee name.

For device groups, the search shows you which groups contain a particular device type. For employee groups, the same: search by name and see which groups the employee is assigned to.

Limited — the matrix is optimized for desktop/tablet, you need to scroll a lot on the smartphone.

A mobile-optimized matrix view does not currently exist. For on-the-go use, we recommend using the matrix on a tablet or laptop.

Yes — via My Samedis Care they can share their training with your facility.

The employee selects the target facility in My Samedis Care and shares their training. These arrive with you as “shared training” for approval. You can decide for each device individually whether you accept the training or require new training. The system automatically suggests only devices that are actually in your inventory.

Yes — the My Samedis Care account is independent of the facility.

All training documented in Samedis Care is automatically also saved in My Samedis Care. When changing employers, the employee retains their complete digital device passport. With the recovery email address, they can access their account even if the old business email no longer works.

Under Contacts > Employees > New — Minimum: first name, last name, and start date.

Optionally you can capture employee number, email address, department, and position. The employee number is important for reconciliation with HR interfaces to avoid duplicates. Tip: If you don’t know the employee number, create the employee anyway — this can be corrected later.

Set up the same as permanent employees — they also need training certificates.

Temporary workers are typically not set up via the HR interface. Therefore, you must capture them manually. This can also be done directly from the training dialog (ad-hoc setup). Recommendation: Point borrowed staff to My Samedis Care — there they can bring their digital device passport and share training with your facility.

Then you lack write permission for employee management.

Contact your application administrator to grant you the appropriate right in access management. Alternatively, you can also create employees directly from the training dialog — you only need permission to document training.

Merge employees: Open record > More > Merge.

Select the target record and all training, group memberships, and assignments will be automatically transferred to the target record. Warning: This cannot be undone — check first that it is really the same person.

Set exit date — don’t delete!

The exit date ensures that the employee is removed from training statistics and no longer appears as requiring training in the matrix. The training documentation remains completely intact. For temporary absence (parental leave, sabbatical): Also set exit date, and when returning, remove the exit date and set new start date. You do not need to keep an entry/exit history — this is automatically logged in the background.

A public overview of all employees assigned to certain positions.

Under Facility > Positions you create roles (e.g., “Medical Device Officer”, “Application Administrator”) and determine whether they are visible in the directory. Employees with these positions then appear in the directory — visible to all users of the facility and in My Samedis Care. This way, everyone knows who to contact.

Scan QR code on device > Malfunction Report > enter text or take photo/video > submit.

The report goes to the responsible person (internal technician or external service provider). The advantage: the system automatically knows which device it is and who made the report. Videos are particularly helpful — for example, with unusual noises.

Yes — directly from a repair action.

Select the contact as recipient, adjust the auto-generated text if needed, attach photos and send. The system creates an email with all inventory and action information. Responses from the service provider go directly to the employee who created the action — not to Samedis.

Central announcements about problems with medical devices — e.g., BfArM announcements or manufacturer recalls.

Samedis Care automatically checks whether affected device types are in your inventory and creates a safety action if necessary. You will be notified and can process, document, and close the action. This is important for your risk management — during inspections you must be able to show that you took care of security announcements.

Two ways: My Samedis Care (digital) or Employee Management > Training (PDF report).

The report contains all documented trainings with date, device type, trainer, and — for digital documentation — signatures. For paper training only the action number is listed as a reference. Each employee can also view this report themselves via My Samedis Care.

Yes — there is an export button in every list and matrix.

The export is created in the background and made available via the bell (notification). For the matrix, colors are transferred as cell background colors (not as font color). The export also includes information about which filters were set.

The official list of all active medical technology devices — what you show during inspections.

Non-medical technology devices (computers, printers, etc.) do not appear there if you have set the “Not a medical technology device” checkbox. In addition, there is the inspection report (last and next inspection per device) and the medical device documentation (complete history of a single device).

Click “Reset” — this removes all filters, sorts, and column customizations in one go.

All lists remember your settings (filters, sorting, columns) on your respective device. If you are missing data, it is usually a forgotten filter. Yellow-marked filter fields indicate that a filter is active. You can also reset filters individually.