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.
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MEDICAL DEVICES · ORGANISATIONAL FIT
AI for medical device QA/RA: where traqx fits.
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.
THREE CONCRETE SITUATIONS
How traqx prepares groundwork in medical-device quality work.
Each situation shows the controlled input, one agent task, the reviewable result and the manufacturer's boundary.
Update a QMS procedure against controlled sources
CONTROLLED INPUTS
Existing QMS procedure, the manufacturer's internal policy, current document template and customer-selected MDR sources.
AGENT TASK
SOP Agent · Compares the procedure with the policy, template and selected sources and prepares a justified update.
REVIEWABLE RESULT
Word file with tracked changes, source and rationale comments, and an updated version history.
HUMAN / SYSTEM BOUNDARY
The manufacturer assesses applicability and regulatory acceptance and releases the document through its own QMS.
Pre-review a defined technical documentation package
CONTROLLED INPUTS
Manufacturer-defined technical documentation package, approved controlled checklist, selected evidence and applicable manufacturer sources.
AGENT TASK
Reviewer Agent · Checks the package against the controlled criteria and separates evidenced coverage from contradictions and gaps.
REVIEWABLE RESULT
Review list with evidenced gaps, contradictions and the affected document passages.
HUMAN / SYSTEM BOUNDARY
The manufacturer decides on completeness, conformity and release; traqx is neither a RIM nor a design-control system.
Review production or QMS software within the actual assurance scope
CONTROLLED INPUTS
Defined use of the production or QMS software, approved user requirements, risk assessment, test records and current trace matrix.
AGENT TASK
Validation Agent · Compares requirements, risks, tests and traces within the documented assurance scope.
REVIEWABLE RESULT
Deltas, a gap list and traceability candidates linked to the provided evidence.
HUMAN / SYSTEM BOUNDARY
The assurance expert defines scope and evidence; FDA CSA is framed only for production and QMS software.
CONTROLLED WORKING MODEL
traqx keeps sources and groundwork connected. QA/RA decides.
The concrete manufacturer process determines sources and boundaries; the medical-device label does not create a blanket regulatory assumption.
- 01 · SCOPE
Separate 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 - 02 · GENERATE
Prepare a draft or update
traqx researches inside the source room and prepares document changes, rationales or traceability suggestions.
Result · reviewable groundwork - 03 · VERIFY
Check sources, status and gaps
Evidence passages and open points remain visible; different regulatory contexts are not silently treated as equivalent.
Result · bounded claim scope - 04 · REVIEW
Assess 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.
OPTIONAL PROCESS EXTENSION: A separately bookable GxP module is only added when a recurring process also needs a preconfigured method, templates, defined work objects and a review path. When a GxP module is added →
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.
PRODUCT EVIDENCE, NOT AN INDUSTRY 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.
Trust Architecture → View product dossiers →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.
FRAME THE MEDICAL-DEVICE PROCESS
Test the fit on one real quality process.
In the meeting, we define the source room, agent task, review and existing manufacturer-system boundaries for one real process.
Book a meeting →Other industries: All industries · Pharmaceuticals · Biotech · CDMO / CMO · Contract research organizations