MEDICAL DEVICES · DOES IT FIT US?

Technical documentation,
QMS work: with evidence.
Your team decides.

traqx prepares SOP updates, documentation reviews and assurance groundwork from your approved sources — with tracked changes, source comments and visible gaps. Assessment, the conformity decision and release stay with your QA/RA team in your own QMS.

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WHAT YOUR TEAM GAINS

Documentation upkeep binds your QA/RA team — traqx prepares it in reviewable form.

Updates with visible origin
SOP and documentation changes arrive source-bound from your approved requirements.
Pre-checks against defined criteria
Gaps and deviations are flagged before your team assesses.
Conformity is your team's decision
traqx assesses no conformity and sets no release — assessment stays in your own QMS.

THREE CONCRETE SITUATIONS

How traqx prepares groundwork in medical-device quality work.

Each situation shows controlled input, one agent task, a reviewable result and the manufacturer's boundary.

01Update a QMS procedure against controlled sources

CONTROLLED INPUTSExisting QMS procedure, internal manufacturer policy, current document template and customer-selected MDR sources.

WHAT TRAQX DOESSOP Agent · Compares the procedure with the policy, template and selected sources and prepares a justified update.

REVIEWABLE RESULTThe updated procedure as a Word file — tracked changes with source and rationale comments, history updated.

WHAT YOUR TEAM DECIDESThe manufacturer assesses applicability and regulatory acceptance and releases the document through its own QMS.

02Pre-review a defined technical documentation package

CONTROLLED INPUTSManufacturer-defined technical documentation package, approved controlled checklist, selected evidence and manufacturer sources.

WHAT TRAQX DOESReviewer Agent · Checks the package against the controlled criteria and separates evidenced coverage from contradictions and gaps.

REVIEWABLE RESULTReview list with evidenced gaps, contradictions and the affected document passages.

WHAT YOUR TEAM DECIDESThe manufacturer decides on completeness, conformity and release; traqx is neither a RIM nor a design-control system.

03Review production or QMS software within the actual assurance scope

CONTROLLED INPUTSDefined use of the software, approved user requirements, risk assessment, test records and current trace matrix.

WHAT TRAQX DOESValidation Agent · Compares requirements, risks, tests and traces within the documented assurance scope.

REVIEWABLE RESULTDeltas, a gap list and traceability candidates linked to the provided evidence.

WHAT YOUR TEAM DECIDESThe assurance expert defines scope and evidence; FDA CSA is framed only for production and QMS software.

The manufacturer's process determines sources and boundaries — the medical-device label creates no blanket regulatory assumption.

01SCOPESeparate MDR, QMS and process sources
Technical files, QMS documents, SOPs, templates and applicable external requirements are assigned to the work object.
Result · defined source room
02GENERATEPrepare a draft or update
traqx researches the source room and prepares changes, rationales or traceability suggestions.
Result · reviewable groundwork
03VERIFYCheck sources, status and gaps
Evidence passages and open points remain visible; regulatory contexts are not silently treated as equivalent.
Result · bounded claim scope
04REVIEWAssess and decide as the manufacturer
QA/RA and subject-matter experts correct, accept or reject. The accountable release path remains in place.
Result · human decision

FIT / BOUNDARY

A fit for controlled quality work, not for product or QMS control.

MDR, FDA CSA and any other applicable context are framed separately for each work object.

✓ FITS

Document, SOP, assurance and audit groundwork

Your team works from defined quality and product sources, needs traceable drafts or updates and retains assessment and decision.

— DOES NOT FIT AS

eQMS, RIM, design control or medical device

traqx does not replace systems of record, control a design-control process or promise a medical-device or diagnostic function.

EVIDENCE, NOT A MARKETING CLAIM

Inspect the control logic in the system state.

traqx is EU-hosted and works in controlled source rooms; customer documents stay within the agreed tenant and hosting scope and are not used for model training. Experts review and decide. The product dossiers show real system views with synthetic demo data—not medical-device customer outcomes.

View practice case & product dossiers →Trust System →

VISIBLE PRIMARY SOURCES

Medical-device and assurance scope remain separate.

EUR-Lex · Regulation (EU) 2017/745
Article 10 addresses the general obligations of manufacturers; Annex II addresses technical documentation. The source does not establish an eQMS, RIM or design-control product claim for traqx.
FDA · Computer Software Assurance for Production and Quality Management System Software
The final FDA guidance addresses software used in production or quality management systems. It is not carried over here to software as a medical device or product functions.

FAQ

Medical-device fit with a clear scope boundary.

Which quality work at medical device manufacturers is traqx a fit for—and what does it not replace?

traqx fits controlled quality and documentation work at medical device manufacturers when QMS documents, technical files, SOPs or assurance evidence serve as defined sources for reviewable groundwork. traqx does not replace an eQMS, RIM or design-control system and provides no medical-device or diagnostic function.

Is every activity at a medical device manufacturer GxP-relevant?

No. The actual process and applicable regulatory context decide. This page does not equate MDR, FDA CSA and pharmaceutical GMP contexts or infer blanket GxP status from the industry label.

Does technical documentation remain in the manufacturer's accountable process?

Yes. traqx checks only the package defined by the manufacturer against the approved sources and criteria and makes gaps or contradictions visible. Assessment, the conformity decision and release remain with the manufacturer.

Does FDA CSA also apply to software as a medical device?

The FDA guidance linked here addresses computer software assurance for software used in production or the quality management system. This page does not extend that scope to software as a medical device or embedded product software.

Technical documentation,QMS work: with evidence.Your team decides.

Documentation upkeep binds your QA/RA team — traqx prepares it in reviewable form.

How traqx prepares groundwork in medical-device quality work.

Mapped traqx use cases for this industry.

SOP management

Change Control

CAPA

Audit readiness

Supplier Assessment

CSV / CSA · production/QMS

Process validation / CPV

Equipment qualification

traqx keeps sources and groundwork connected. QA/RA decides.