01
Certification audit
Initial assessment of an ISO 13485 quality management system.
Medical-device audit support
ISO 13485 Audits
Specialist interpreting for certification, surveillance and supplier audits of medical-device quality systems.
Discuss this projectQMS communication
1Audit team
2QMS specialist
3Device manufacturer
BriefGlossaryOn-site continuity
Why preparation matters
Quality conversations carry technical and regulatory context
ISO 13485 audits connect quality management, risk management and the complete device lifecycle. Exact terminology helps the audit team follow that connection without unnecessary clarification cycles.
Quality management systemRisk managementDesign and developmentCAPA and complaintsDevice lifecycleRegulatory requirements
Typical objects
Class I–III devicesIVDActive devicesImplantsSterile devicesSoftware as a medical device
When we support
Built around the assessment format
02
Surveillance audit
Periodic maintenance and verification of an existing certification.
03
Supplier audit
Assessment of device-component and critical-service suppliers.
04
Pre-certification
Readiness review before the formal conformity assessment.
Project outcomes
What a prepared linguistic workflow protects
QMS fluency
Communication follows the language of ISO 13485 and controlled procedures.
Risk context retained
Hazards, controls and residual risks remain connected in discussion.
Lifecycle consistency
Terms stay aligned from design controls through post-market processes.
Audit-ready handover
Decisions and agreed vocabulary are captured for follow-up.
How we work
Six controls from enquiry to closing meeting
01
Request analysis
Site, dates, languages and confidentiality requirements.
02
Program and scope
Agenda, roles and terminology areas are mapped.
03
Specialist selection
Language, region and technical experience are matched.
04
Documentation
Approved records and terminology are reviewed.
05
Project glossary
Critical terms are aligned before the event.
06
On-site support
Context is preserved through the closing meeting.
Related experience
Illustrative cases in this service
Case facts remain marked until approved for public use.
Illustrative case
Certification audit of a Class IIb device manufacturer
Sample outcome: Risk-management and QMS terminology remained consistent across the assessment.
View case →Illustrative caseSurveillance audit for an IVD manufacturer
Sample outcome: Regulatory and quality terminology stayed consistent throughout the surveillance assessment.
View case →FAQ
Before the project begins
Do specialists understand medical-device terminology?
Profiles are selected by language pair and relevant QMS, risk-management and device experience.
Are remote audits supported?
Yes. The preparation process can be adapted to on-site, remote and hybrid assessments.
Can terminology be reused after the audit?
The approved project glossary can be handed over for consistent follow-up communication.
Project enquiry
Discuss the inspection before the agenda is fixed
Share the site, dates, languages and type of assessment. We will review the project context confidentially.
Start an enquiryNDA-ready · Specialist selection · Worldwide coordination