Quality & Compliance
Audited. Documented. Released against spec.
Every Aurum product is built inside a single, audited quality framework — from material intake to post-market surveillance. We invite hospital buyers, regulators and global partners to audit it.
Certifications
A multi-certificate quality posture.
ISO 13485:2016
Medical Device QMS — covering design, manufacture and post-market surveillance of medical devices.
ISO 9001:2015
Quality Management System — applicable to all hygiene, baby care and wellness manufacturing lines.
WHO-GMP
Good Manufacturing Practice — facility-wide compliance for sterile and non-sterile production.
CE Technical File
EU MDR-aligned technical documentation maintained for export device families.
US FDA Establishment
Registered manufacturing establishment supporting US institutional buyers.
GMP Cosmetic
Cosmetic GMP compliance for intimate wash, creams and personal care products.
The release process
Six gates between raw material and dispatch.
- 01
Material intake
Every incoming lot is sampled and released by QC before entering production.
- 02
Clean room production
ISO Class 7 & 8 environments with HEPA-filtered air and gowning protocols.
- 03
In-process control
Validated checkpoints with statistically sampled inspection at every stage.
- 04
Sterilization
ETO and gamma sterilization with parametric release and dosimetric verification.
- 05
Batch release
Independent QA signoff against design-input specs before any product leaves the facility.
- 06
Post-market surveillance
Complaint, adverse-event and CAPA system feeding back into design controls.