For certifiers and authorities in the healthcare sector
Traceable assessment for complex technical documentation.
A centrally hosted, browser-based workspace for evaluating technical documentation in the EU healthcare sector. AI is built into every step of the review, breaking down even the most complex manufacturer dossiers. The result is one coherent argument against the MDR, not a pile of disconnected findings. Certification experts are empowered to focus on transparent, traceable evidence review, enabling them to apply their expertise and accountability to well-founded conclusions.
AI assists the review. Auditors own every conclusion. No autonomous certification decisions.
AI from start to finish
A product model, coordinated with the auditor, carries every step, so results stay coherent instead of locally plausible and unaware of the rest of the file.
Human judgment
Auditors control every conclusion and disposition.
Traceable citations
Open claims to the exact sentence, table, or figure.
Expert reviewers should not spend their expertise hunting files.
When large, multi-format submissions live in nested folders, email, and disconnected tools, the reviewer must first find their way, reconstructing context instead of exercising judgment.
TDVeriX Med is built for evidence review in the browser, not document archaeology on a local drive.
- Documentation overload: large, heterogeneous packages under time pressure
- Inconsistent review depth across assessors and sampling choices
- Weak traceability from observations to MDR criteria and source material
- Throughput limited when reading alone must scale with dossier volume
- Assessment project state scattered across shared drives, tools, and status meetings
Regulation
The phase the regulation actually clocks
Implementing Regulation (EU) 2026/977 caps product verification at 90 days from initiation of technical-documentation assessment to final review. TDVeriX Med helps leads, auditors, and reviewers spend that window on evidence and disposition, not on finding their way through manufacturer-specific TD dossiers.
Articles 1-3 apply to agreements signed on or after 25 February 2027. Stage definitions and caveats.
Initial certification: maximum stage durations
Application review and contract
Complete application received → contract signed
30 days
Quality management system audit
First audit activity → QMS final review complete
120 days
Product verification (technical documentation)
TD assessment initiated → product verification final review
90 days
Decision and certification
After final review → certificate issued and Eudamed entry
20 days
From TD submission to defensible assessment
A path that starts where assessment begins, without handing ownership of the decision to software. The workspace stays context-aware throughout the assessment: each new piece of context is compared with the product model already in place and weighed for what it changes in the picture as a whole. Analyses are therefore meaningful, not piece-by-piece readings that produce findings with no picture of the device.
- 01
Take over the TD submission dossier
Adopt the manufacturer's TD dossier, assign the assessment team, and configure the assessment.
- 02
Navigate the TD dossier
Work from the searchable dossier. Documents, tables, images, and other inputs live in one workspace built for auditor review.
- 03
Sample, then model the product
Review coverage of the TD and grouping proposals by regulatory, technological, and risk criteria. Once sampling is decided, the workspace builds a product model of the device under review, flexible enough for the range of products the MDR covers.
- 04
Assess from that model
Configurable assessment tasks run against the model, not as independent document queries. Completeness, consistency, GSPR fit, and evidence quality are judged in the same picture the auditor will have to defend.
- 05
Review and disposition
Evaluate analysis that already knows the product as a whole. Set dispositions, select legal references, and record the professional judgment, without first reconstructing what disconnected findings were trying to say.
- 06
Produce the record
Assemble approved work into an exportable, traceable assessment package.
The assessment workspace
What needs a call is already in front of you. One hosted workspace for the whole submission, so expertise goes to the review, not to hunting nested archives, unsearchable files, and local copies.
01 · Portfolio
Screenshots were edited for data privacy. All data is fictional. Any resemblance to existing products, persons, or companies is unintentional.
The live work, not a shared drive
One place for what matters now
The case in review, what is still being processed, and what is ready, without reconstructing status from drives, mail, and meetings.
One searchable case
Thousands of files, gigabytes of data unpack into a single indexed case, not a folder tree on someone's laptop.
Every format, one dossier
Scans, images, tables, and files across formats and languages become a reviewable dossier before anyone opens a single document.
The auditor sees the evidence, controls the language, and makes the call.
Supporting analyses are not finished answers, and they are not a findings dump. They are a coordinated draft of the assessment you would otherwise have to reconstruct yourself, still verified at source before anything enters the record. A pile of fragmented output forces the auditor to assess twice: once the product, and once the tool.
In typical workflows of certifiers and authorities, disposition authority stays with the auditors. Reviewers and leads contribute within the roles your procedures define.
Sources at the word level
Open the sentence, figure, or table behind a draft, not just the parent file.
Requirement-aware
Keep regulatory and procedural context in sight while you review.
Editable
Revise or reject assisted text before it enters the assessment report.
Uncertainty visible
Flag incomplete, conflicting, or insufficient evidence.
Action traceable
Retain a history of review, disposition, and who owned the call.
How assessments run in practice
Portfolio visibility, manufacturer exchanges, and revision history stay with the assessment project, so teams spend less time reconstructing state.
- 01
Portfolio oversight
Filter assessment projects by status, see ownership and progress, and coordinate leads, auditors, and reviewers without the workspace becoming a control authority.
- 02
Manufacturer exchanges
When a finding is tied to the requirement, context, and source, manufacturers can respond more precisely, and the exchange closes when the work is done.
- 03
Revision history
Amended technical documentation stays versioned with the assessment project. Prior packages, changes, and findings remain inspectable.
Sensitive evidence. Accountable work.
Dedicated single-tenant deployment, participant-only access, human disposition, and inspectable history — not a badge row.
- Your evidence stays under your control
- Single-tenant deployment in the EU with participant-only project access and Zero Data Retention (no storage of inputs/outputs) for each AI inference.
- People stay accountable
- Human disposition on every conclusion; assistance disclosed; no autonomous certification.
- You can show what happened
- Pipeline and workflow history with reviewer dispositions: inspectable assessment record.
Built for designation
Introducing new assessment software can itself require evidence, review, and internal approval. TDVeriX Med is designed with that process in mind.
Where TDVeriX Med has already been accepted in an initial designation context, the resulting evidence can be reused for further designations - with full transparency for the Joint Assessment Team. Organizations do not have to start from zero to achieve recognition.
- 01
Reusable evidence
Access structured evidence covering the platform, deployment model, controls, workflows, and AI-assisted functionality.
- 02
Review history
Understand what has already been examined, under which scope, and what evidence supported the review.
- 03
Your assessment remains yours
Prior review accelerates your evaluation; it does not replace your procedures, professional judgment, or accountability.
Start from an established evidence base, then assess TDVeriX Med against your own procedures and requirements.
One platform. A growing body of assessment evidence.
Start with one workflow. Expand with confidence.
The infrastructure should be assessed and aligned with the organization's requirements.
- 01
Discover
Map procedures, templates, roles, and project flow - and identify the evidence your organization needs to approve the platform.
- 02
Configure
Align TDVeriX Med with workflow and access model.
- 03
Pilot
Launch with a defined team or assessment stage.
- 04
Validate
Test with representative or historical dossiers.
- 05
Expand
Refine governance and extend where appropriate.
Toward an assessment that holds together.
Share a representative TD dossier. We will show you how TDVeriX Med opens it up for review.