Every device is tested before it carries our name
Quality in medical technology is not a marketing line — it is a documented process. Each device we build or supply passes electrical safety, functional and performance testing, and the results are recorded against its serial number before it ships.
That record stays with the device. When a hospital calls us three years later, we can look up exactly how the unit left the factory, what has been serviced since, and which parts were replaced.
Standards we work to
Our quality system and product testing follow the international standards that hospital procurement and regulatory review expect.
ISO 13485
Quality management system for the design and manufacture of medical devices.
ISO 9001
Organisational quality management across procurement, service and administration.
CE marking
Conformity assessment and technical documentation for the applicable device classes.
IEC 60601
Electrical safety and essential performance testing for medical electrical equipment.
How we control quality
Design control
Requirements, risk analysis and design reviews are documented before a device goes into production, with change control on every revision afterwards.
Supplier qualification
Components come from audited suppliers against agreed specifications; incoming goods are inspected and sampled before release to production.
In-process inspection
Assembly is checked at defined stages so a fault is found at the bench rather than at the hospital.
Final testing & release
Electrical safety, calibration and full functional testing on every unit, signed off and archived against the serial number.
Traceability & post-market
Serial-level records, complaint handling and field feedback feed back into design and supplier reviews.
Quality does not end at delivery
Installation, commissioning, training and preventive maintenance are part of the same quality system as manufacturing — carried out by our own engineers to written procedures.
Certificates & documents
Replace these placeholder entries with your own certificate files before publishing. Standards are listed as the framework we work to — upload the issued certificates that apply to your company.