Incoming spectroscopy
Raw titanium, stainless and cobalt-chromium verified for composition and certified against ASTM standards.
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Quality Assurance
A quality system built on traceability, not paperwork.
Regulatory compliance is proven in the record behind every device — material certificate, machining data and inspection results, from raw billet to sterile tray.
Certifications
Standards we hold across the product line
ISO 13485:2016
Quality Management
CE Marked
EU Conformity
FDA 510(k)
Cleared Devices
CDSCO Registered
Regulatory Facility
Quality Controls
Control points across the production cycle
Quality is embedded at every stage — not inspected in at the end.
In-process gauging
Critical dimensions checked during machining so deviations are caught before a part advances.
CMM final inspection
Coordinate-measuring machines verify finished tolerances to ±0.01 mm before release.
Surface & passivation
Roughness and corrosion-resistance controls confirm surfaces are ready for long-term implantation.
Sterile packaging validation
Validated packaging protocols keep devices sterile and ready for the operating room.
Full batch traceability
Lot control links every finished device to its complete manufacturing and inspection history.
Documentation
Every device ships with a pedigree.
Procurement and clinical teams can request the compliance documentation that supports each order — from certificates of conformity to material test reports.
- Certificate of ConformityConfirming the device meets its declared specification.
- Material Test ReportsTraceable composition and mechanical data for each batch.
- Sterilisation recordsValidated cycle documentation for sterile-supplied devices.
0Devices shipped with documented batch traceability
0Tolerance verified on critical implant features
0International standards maintained across the line
Compliance
Need certification documents for a tender?
Request our compliance pack and our team will provide the documentation your procurement process requires.