Certified medical devices: digital evidence for traceability and surveillance

Certification of inspections, maintenance and vigilance reports on medical devices with legally valid digital evidence.

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Manufacturers, distributors and healthcare operators managing medical devices must ensure traceability, technical documentation and post-market surveillance throughout the product lifecycle. The European MDR Regulation (EU 2017/745) requires unique device identification (UDI), documentation retention for at least 10 years, and incident reporting.

Photos, videos and documents collected during inspections and maintenance often lack certain dates and integrity guarantees. TrueScreen certifies every documentation phase with immutable metadata, timestamps, cryptographic hash and digital signature, producing legally valid evidence compliant with the eIDAS Regulation.

Industry

Medical devices, healthcare, biomedical, pharmaceutical

Business function

Quality and regulatory affairs, Clinical engineering, Biomedical maintenance, Vigilance, Legal department

Key process

Inspection and verification certification, maintenance documentation, vigilance reports, lifecycle traceability, post-market surveillance

Certified content

Photos, videos, operational checklists, inspection reports, maintenance reports, incident reports, technical documentation

Output

Certified documentation and reporting with legal validity

Adoption mode

App / Web / API / SDK

Needs

  • Technical documentation collected with heterogeneous tools without integrity guarantees

  • Vigilance reports lacking certified evidence with legally opposable certain dates

  • Inspections documented with untraceable and easily contestable photos and reports

  • MDR documentation retention for 10-15 years difficult to sustain without certification

  • Excessive time to consolidate post-market surveillance documentation and reports

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Solution

TrueScreen integrates into medical device management processes, enabling clinical engineers, maintenance technicians and quality managers to certify every documentation phase directly in the field.

Photos of device conditions, verification videos, completed checklists and inspection reports automatically receive immutable metadata: timestamps, geolocation, cryptographic hash and digital signature compliant with the eIDAS Regulation.

The certified documentation is opposable during competent authority inspections, in vigilance reports and in legal proceedings, ensuring compliance with MDR Regulation obligations throughout the entire device lifecycle.

What gets certified

Medical device condition

Photos and videos of operating conditions, components and UDI labelling

Maintenance interventions

Documentation of operations performed with certified checklists and chronological register

Periodic inspections and verifications

Inspection reports with detection of conditions and measurements performed

Vigilance reports

Photographic and video documentation of anomalies detected with certain date

Expected benefits

  • Medical device documentation certified and traceable throughout the entire lifecycle

  • Vigilance reports supported by evidence with certain date and legal validity

  • MDR Regulation and D.Lgs. 137/2022 compliance without additional operational burden

  • Elimination of manual transcriptions with structured and certified digital reporting

  • Post-market surveillance files ready for audits and ministerial inspections

Partners

Medical device manufacturers, authorised distributors, public and private healthcare facilities, clinical engineering services, biomedical maintenance companies, notified bodies, certification bodies and law firms specialised in healthcare law can integrate TrueScreen into their operational workflows.

Integrations

TrueScreen integrates with quality management systems, biomedical CMMS, post-market surveillance platforms, EUDAMED databases and document archives. Certified reports are exportable in PDF and JSON format, compatible with major archiving systems and reporting platforms for competent authorities.

FAQ: certified medical devices and traceability

1) How does TrueScreen certify medical device documentation?
TrueScreen certifies photos, videos, checklists and inspection reports acquired during medical device verifications. Each piece of content automatically receives immutable metadata, cryptographic hash and digital signature, producing documentation with full legal validity.
2) Is TrueScreen certification compliant with the MDR Regulation (EU 2017/745)?
Documentation certified with TrueScreen complies with European MDR Regulation requirements for traceability, document retention and post-market surveillance. The evidence produced meets eIDAS Regulation standards and is opposable during inspections and in legal proceedings.
3) What types of medical device documents can be certified?
It is possible to certify photos of operating conditions, verification videos, maintenance checklists, inspection reports, incident reports and any technical documentation related to the medical device lifecycle.
4) How does UDI traceability work with TrueScreen certification?
TrueScreen allows documenting and certifying UDI labelling of medical devices with photos featuring certain dates and immutable metadata. The certified documentation supports unique identification obligations under the MDR Regulation throughout the entire device lifecycle.
5) How are vigilance reports managed with certified evidence?
In case of anomaly or incident, the vigilance officer acquires and certifies evidence with TrueScreen, obtaining proof with certain date, verifiable geolocation and digital signature. The documentation is prepared for reporting to competent authorities and is opposable in legal proceedings.
6) Can certified reports be integrated into quality management systems?
Reports generated by TrueScreen are exportable in PDF and JSON format, compatible with major quality management systems, biomedical CMMS and post-market surveillance platforms. Documentation is structured and immediately available for audits and ministerial inspections.

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