Biomedical CMMSReport Application
Report Application
Medical Equipment Maintenance
Digitize your biomedical interventions. Preventive maintenance, quality control, traceability - professional PDF report.
Free 7-Day TrialEquipment Types
Imaging
CT Scanner, MRI, ultrasound, radiology.
Monitoring
Monitors, ECG, oximeter, defibrillator.
Laboratory
Analyzers, centrifuges, automated systems.
Operating Room
Tables, lighting, electrosurgery, ventilator.
Patient Care
Beds, pumps, syringe drivers.
Dental
Chairs, radiology, sterilization.
Features
Mobile CMMS
Equipment records, intervention history, parts.
Quality Control
QC protocols, measurements, standards compliance.
Traceability
Serial number, batch, expiry date, maintenance.
Photos
Intervention documentation with photos.
Offline Mode
Work in the facility without Wi-Fi.
PDF Report
Professional report for equipment file.
Frequently Asked Questions
What are the maintenance obligations for medical devices?+
Decree No. 2001-1154 of December 5, 2001 requires: preventive maintenance per manufacturer recommendations, periodic quality control (internal or external), traceability of all maintenance operations in a dedicated register. Materiovigilance (incident reporting) is mandatory (article L.5212-2 of the Public Health Code). Biomedical equipment is classified by criticality (Class I, IIa, IIb, III per EU regulation 2017/745).
Which medical equipment requires external quality control?+
ANSM sets by decision the equipment subject to mandatory external quality control (EQC): radiology equipment and scanners, mammographs (annual), radiotherapy equipment, ultrasound (no mandatory EQC but recommended), implantable defibrillators. The control is performed by a COFRAC-accredited external quality control body. Results must meet the acceptability criteria set by ANSM decision.
How to organize hospital biomedical equipment management?+
Comprehensive inventory (CMMS - Computerized Maintenance Management System), criticality classification (patient risk x frequency of use x availability of replacement equipment), preventive maintenance plan based on manufacturer recommendations and field experience, renewal policy (average lifespan, obsolescence, maintenance cost vs replacement), user training, and regulatory monitoring (EN IEC 62353 standards for electrical safety checks).
What is the EN IEC 62353 standard for electromedical device safety?+
EN IEC 62353 standard (formerly EN 62353) defines periodic electrical safety tests for in-service electromedical equipment. It replaces the practice based on EN 60601-1 (design standard) for field checks. Tests include: visual inspection, protective earth resistance measurement, leakage current measurement, insulation verification. Results are compared to standard limits. Recommended frequency: annual.
What is materiovigilance and when should an incident be reported?+
Materiovigilance is the surveillance system for medical device incidents (articles L.5212-1 et seq. of the Public Health Code). Mandatory declaration to ANSM by healthcare professionals in case of: serious incident (death, serious health deterioration), risk of serious incident, recurrent malfunction. Reporting is done on the ANSM portal within 24 hours of becoming aware of the incident. The manufacturer also has a reporting obligation.