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NaDIAby Native Digital

NaDIA for clinical engineering

From asset to compliance.

NaDIA manages the technical and regulatory documentation of medical equipment, from commissioning to audit. It centralises it, indexes it and makes it available straight away.

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NaDIA

Question: Which pieces of equipment in Intensive Care have their electrical safety test due in the next 60 days?

In the next 60 days, the tests on three pieces of equipment fall due:

  1. 1.Ventilator, serial VP-20417: by 14 November 20261.
  2. 2.Infusion pump, serial PI-88213: by 2 December 20262.
  3. 3.Defibrillator, serial DF-03391: by 19 December 20263.

The report on the infusion pump’s last test lacks the head of department’s signature2: the document has already been sent back for completion.

To doschedule the three tests and have the missing signature added.

Sources

  1. 1PDFDevice file VP-20417IEC 62353 test report, November 2025
  2. 2PDFDevice file PI-88213IEC 62353 test report, December 2025Missing signature
  3. 3XLSXDevice file DF-03391Preventive maintenance plan 2026
Example with invented data.

Documentation under pressure from three sides.

Clinical engineering departments handle growing volumes of heterogeneous documents, spread across departments, suppliers and systems.

  1. 1Heterogeneous data

    Acceptance tests, manuals, CE certificates and delivery notes are spread across departments, suppliers and systems that do not talk to each other.

    • Delivery notesupplier
    • Acceptance reportdepartment

  2. 2Regulatory and legal risk

    Expired documents, revisions not formally approved, missing signatures on critical forms.

    • CE certificateExpired
    • IEC 62353 testUnsigned

  3. 3Traceability across the life cycle

    Duplicates, inconsistent versions across departments and audits that take a long time.

    • User manualrev. 2
    • User manualrev. 3, copy

Technical documentation, examples.

A single hub, from scattered documents to governed data.

NaDIA captures, classifies, validates and makes searchable the technical and regulatory documentation of every device, on a single platform.

  1. 01SAT/FAT acceptance testsreports, IEC 62353 checklists
  2. 02CE certificationsdeclarations, warranties, safety notices
  3. 03Maintenanceplans, work orders, reports, spare parts
  4. 04Trainingattendance registers, certificates, deadlines
  5. 05Contracts and SLAswarranties, extensions, penalties, calibrations
  6. 06Manuals and filesuser manuals, technical files, delivery notes

Device file

One per device

  1. 01Captures
  2. 02Classifies
  3. 03Validates
  4. 04Makes searchable

The device file, from commissioning to decommissioning.

All of a device’s documents in a single view, with search by meaning and filters by department, period and compliance status.

  1. 01

    Commissioning

    The acceptance test package, generated and tracked: SAT/FAT reports, IEC 62353 checklists, photo attachments.

  2. 02

    CE certification

    Declarations of conformity, manuals, firmware updates, safety notices.

  3. 03

    Maintenance

    Preventive maintenance plans, work orders, service reports, functional checklists.

  4. 04

    Decommissioning

    The close of the life cycle, with traceability and retention of the historical file.

Without a dedicated hub. With NaDIA.

Without a dedicated hub

  • 01Document search

    Long search times and fragmentation: the latest valid revision is hard to find for an audit.

  • 02Compliance and audit

    Clinical and legal risk from expired documents or missing mandatory signatures on critical forms.

  • 03Lifecycle management

    Duplicated and inconsistent data across clinical engineering, suppliers and departments.

With NaDIA

  • 01Document search

    Search by meaning in a single archive: the latest valid revision is found straight away.

  • 02Compliance and audit

    Audit-ready dashboards, with alerts on expiry dates, revocations and the completeness of each file.

  • 03Lifecycle management

    A single device file for each piece of equipment, traceable and verifiable.

Six use cases, from acceptance testing to contracts.

Acceptance testing and commissioning

Guided collection of test reports, checklists, photographs, manuals and declarations of conformity.

  • SAT/FAT reports and IEC 62353 checklists
  • Photos and manuals in the same file
  • Acceptance package generated automatically, approved and tracked

Ventilator

VP-20417 · Intensive Care

  • PDFSAT reportsigned by the technician and the manager
  • PDFIEC 62353 checklist
  • JPGInstallation photos4 images
  • PDFUser manual
  • PDFCE declaration of conformity
Acceptance package complete and tracked

Preview with invented data.

What it reads, even handwritten.

Documents arrive through many channels. NaDIA recognises them, classifies them and links them to the right device file, with no manual data entry.

  1. 01Capture

    • Drag and drop
    • Bulk import
    • Incoming email
    • Network folders
    • Scanner
    • Suppliers

  2. 02Recognition

    NaDIA reads
    Data filled in by hand
    Ticks in boxes, serial numbers and dates written in pen, quantities, notes.
    Mandatory signatures
    Present or missing, for technicians, managers and training participants.

  3. 03Classification

    • document type
    • device
    • serial number
    • department
    • supplier
    • dates and deadlines

  4. 04Device file

    Device file

    NaDIA then links the document to the device file.

Dashboards for deadlines, signatures and contracts.

The dashboards show which signatures are missing and which documents are about to expire. That way you reduce legal risk and keep your supplier contracts under control.

PlannedAvailable soon.

A review and approval workflow with qualified or advanced digital signatures and document versioning.

01NaDIA detects missing signatures on critical documents and sends the document back to whoever needs to complete it.

Missing signature

IEC 62353 test report for infusion pump PI-88213

Signature of the head of departmentmissing

Returned to the department for completion.

02A schedule of deadlines for certifications, calibrations, training, warranties, extensions and penalties.

  • Supplier SLAs

    1to renew

  • Calibration certificates

    3expiring

  • Warranties

    5expiring

03Reports on compliance evidence, on how complete the files are and on the gaps to close.

212complete CE files

3to update

Compliance dashboard, example with invented data.
Preventing clinical risk begins with qualifications.

NaDIA reads the sign-in sheets of technical courses and gives advance notice of mandatory refresher training, so that critical equipment is not used by staff whose qualifications have expired.

PlannedAvailable soon.

Data Bridge, an optional module.

  • Natural-language questions across several of the hospital’s databases (SQL, NoSQL, document stores), without replacing existing applications and without duplicating data.
  • Guided links between different tables and schemas, for example between the document archive and an SQL database already in use.
  • Preview and validation of the generated query.
  • Answers based on the data, with the origin of every data point.
  • The permissions already defined in existing systems are respected, sensitive data is masked, queries are logged.

Data Bridge complements the document archive and does not introduce asset-tracking functions.

NaDIA and PAL

And where, right now, is that device?

In hospitals that use PAL, Native Digital’s battery-free tracking platform, NaDIA also answers questions about where equipment is and whether it is available, in natural language. NaDIA’s document management does not track equipment: tracking stays with PAL, and the two systems complement each other.

Discover PAL(opens in a new tab)

Question

Where are the available infusion pumps on the third floor?

NaDIA answers with PAL’s location data.

Example question.

Security by design and governance.

NaDIA is designed for alignment with the Federal Act on Data Protection (FADP) and the GDPR, for Swiss hospitals and for Italian healthcare facilities.

Integrations

  • IdP / SSO
  • SQL and document databases
  • PEC (certified email)for Italian facilities
  • Records registry (protocollo)for Italian facilities
  • Network folders

  1. 01Access by role and department

    • Access control by role and department, with IdP/SSO integration
    • Segregation by technology and supplier

  2. 02Audit trail and retention

    • Complete audit trail: who, what, when
    • Document retention policies

  3. 03Encryption and backup

    • Encryption in transit and at rest
    • Backup and disaster recovery

  4. 04FADP and GDPR

    • Designed for alignment with the FADP and the GDPR

Why NaDIA for clinical engineering.

  1. 01

    Specific to clinical engineering

    Configured for the document types and processes of the biomedical domain.

  2. 02

    Non-invasive integration

    Connects to existing systems through open standards and does not overlap with asset-tracking systems.

  3. 03

    Active assistance

    Guides staff in preparing a correct and complete documentation package.

  4. 04

    Short timescales

    A gradual, modular introduction, so that you are ready for audit in a short time.

Benefits for the hospital.

Native Digital has carried out a pilot project in a paediatric hospital, with PAL and NaDIA, on the management of information and documentation.

  1. 01Less time searching for documents and preparing technical files.
  2. 02Less risk of non-compliance, with controlled revisions and expiry alerts.
  3. 03Operational continuity: documentation, manuals and safety procedures always to hand in the department.
  4. 04Immediate reports for Management, Quality and Risk Management.
  5. 05Faster onboarding of new suppliers, technicians and equipment.

NaDIA in the other sectors

All sectors

Turn your hospital’s compliance into an operational advantage.

We show you NaDIA using examples of clinical engineering documentation and assess with you how it integrates with your systems.

Request a demo