Quality & Compliance

Every device. Every batch. Fully documented.

Our quality framework operates at every stage — from supplier qualification through to post-market surveillance.

01

Quality Philosophy

We work exclusively with ISO 13485 certified manufacturers. If we cannot verify it, we do not supply it.

02

Incoming Inspection

Every shipment is checked for packaging integrity, label compliance and lot documentation before entering stock. Batches that do not pass are quarantined and not released.

03

Manufacturing Control

Partners operate under certified QMS with in-process inspection at critical control points. We conduct periodic audits to verify controls remain in place.

04

Product Validation

Each device is validated through IQ, OQ and PQ protocols. Risk files are maintained per ISO 14971. Certificates of conformity are available for all product lines.

05

Sterility Assurance

All devices are supplied sterile via EO or gamma irradiation, validated to SAL 10⁻⁶. Sterilisation cycle records are available per lot on request.

06

Traceability

Every unit is linked to its manufacturing batch, sterilisation cycle and distribution record. Data is retained for shelf life plus five years.

07

Continuous Improvement

Complaints, field feedback and audit findings feed into a formal CAPA process. Supplier qualification is reviewed annually.

Certifications & compliance

Documentation available on request.

ISO 13485 Active
Quality Management
All manufacturing partners certified. QMS documentation available.
CE MARKING Select lines
CE Documentation
Technical files and Declaration of Conformity available per product.
CDSCO Active
Importer Registration
AVIORA MedTech is a CDSCO registered medical device importer.
FDA 510(k) Select lines
FDA Clearance
K-numbers confirmed per product line on request.
ISO 14971 Active
Risk Management
Risk files maintained for all devices per ISO 14971.
LOT TRACING All products
Full Traceability
Lot and sterilisation records retained for every unit supplied.