Medical Device Packaging
Cleanroom-built packaging that protects sterile devices — and passes audit.
Customer Challenges
Protect the device, satisfy the auditor, control the cost.
Medical packaging has to pass on cleanliness, compliance and durability at once.
Contamination & bioburden
Particulate and bioburden threaten sterility and downstream compliance.
ISO 13485 & validation
Demands for traceability, validation and documented change control.
Sterile barrier durability
Packaging must survive sterilisation and distribution without compromise.
Cost without compromising compliance
Pressure to reduce cost while holding every regulatory requirement.
Supplier risk
Distant or unaudited suppliers add lead-time and qualification risk.
Audit readiness
Launches stall without audit-ready packaging and documentation.
Konix Solution
Cleanroom-manufactured, validated, fully documented.
We manufacture in ISO-class cleanrooms under ISO 13485. Trays and components protect the device and support the sterile barrier, withstand sterilisation and distribution, and arrive with the documentation and change control your quality system needs.
- ISO 13485 manufacturing in cleanroom-class environments.
- Designed to support the sterile barrier and survive sterilisation.
- Validated for transit and distribution conditions.
- Full documentation and change control for audit.
Applications
Formats we engineer for medical.
Business Benefits
What it means for your KPIs.
Compliance & risk reduction
Cleanroom manufacturing and documentation lower contamination and audit risk.
Quality / RegulatoryControlled cost
Material and format optimisation without touching compliance.
PurchasingFaster, de-risked launch
Audit-ready packaging and documentation keep device launches on schedule.
Program / NPILocal supply assurance
A qualified, audited local source reduces lead-time and supplier risk.
Supply chainEngineering Features
The engineering behind the tray.
ISO 13485 system
Quality management aligned to medical device requirements.
Cleanroom manufacturing
ISO Class 8 & 9 forming, cleaning and packing.
Sterile barrier support
Designs that protect and complement the sterile barrier system.
Validation & testing
Sterilisation compatibility and transit validation to your protocol.
Documentation & change control
Traceable records and controlled changes for audit readiness.
In-house tooling
CNC and soft-tool fabrication with secure mould storage.
Case Study
Diagnostic launch — audit-ready without inflating cost.
A diagnostic launch needed audit-ready packaging without inflating material cost.
Cleanroom-manufactured trays validated for sterilisation and transit, with full documentation.
Audit-ready documentation · fewer contamination complaints · controlled material cost.
Outcomes are directional and vary by device, sterilisation method and validation scope. We model the expected result with you before tooling.
FAQ
Medical packaging questions.
Are you certified to ISO 13485?
Can packaging withstand our sterilisation method?
Do you provide documentation for audit?
Can you be qualified as a local second source?
Request a Solution
Launching or transferring a medical device? Talk to our engineers.
We'll propose validated, cleanroom-built packaging — a recommendation, not a generic quote. A local engineering team in Đồng Nai. Your drawings and data stay confidential.