Biomedical Device
Preliminary / planning-support biomedical-device engineering: device QC workflow framing, calibration / verification planning, maintenance / service SOP drafts, technical-file readiness review, device risk / control review framing, and acceptance / preventive-maintenance checklist support. PRELIMINARY ONLY — does NOT issue regulatory approval (ISO 13485 / IEC 60601 / FDA 21 CFR 820 / EU MDR / ISO 14971), accredited calibration certification, or clinical validation.
Device QC Workflow
StandardDevice-class + use-context QC checkpoint framing (incoming / config / functional / safety / record / release) with manufacturer-IFU binding notes. Non-regulatory — not ISO 13485 / IEC 60601 compliance evidence.
⏱ 3-6 minutes
Calibration / Verification Plan
StandardUsage- and criticality-weighted calibration-interval framing and verification-step outline, with ISO/IEC 17025 traceability note. This service does NOT issue accredited calibration certificates.
⏱ 3-6 minutes
Maintenance / Service SOP
StandardService-level (planned / corrective / condition-based / overhaul) SOP skeleton with hazard-feature sections (electrical LOTO, fluid path, high pressure, radiation, battery) added by declared features. Skeleton only — not an authorised service procedure.
⏱ 3-6 minutes
Technical File Readiness Review
StandardGeneric expected-documents coverage check (design input/output, risk-management per ISO 14971, verification, validation, biocompatibility, sterilisation, electrical safety, software, usability, clinical evaluation, labelling, PMS, QMS, declaration). Coverage indicator only — does NOT perform regulatory assessment.
⏱ 3-6 minutes
Device Risk / Control Review
StandardPreliminary hazard severity × likelihood scoring with band classification (unacceptable / tolerable-with-controls / broadly-acceptable) plus ISO 14971-inspired control hierarchy (inherent design → protective measure → information-for-safety). Draft — NOT an ISO 14971 risk-management file.
⏱ 3-6 minutes
Acceptance / PM Checklist
StandardGeneric acceptance and preventive-maintenance checklist for clinical devices, with environment hints (critical-care, OR, imaging, lab, home). Items must be bound to the manufacturer IFU. Does NOT authorise acceptance or return-to-service.
⏱ 3-6 minutes