Quality & Regulatory
Quality is a process, not a claim
We describe what we do, and publish certification only once the issued certificate is in hand and released by Quality & Regulatory Affairs.
Quality management system
Documented procedures covering design, purchasing, production, inspection and release.
Process validation
Manufacturing and packaging processes qualified and validated according to defined protocols.
Traceability
Batch records linking incoming materials, production steps and finished device release.
Risk management
Product risk assessed across the device lifecycle and reviewed as part of change control.
Quality control
Physical, chemical and microbiological testing on materials, in-process samples and finished devices.
Post-market vigilance
Complaint handling, investigation and corrective action within the quality system.