MEDICAL DEVICE PACKAGING

Medical Device Packaging & Sterile Barrier Dielines

Engineering-grade dielines, breathable Tyvek® peelable pouches, thermoformed tray protective cartons, and certified ISO 15223-1 / UDI regulatory symbol architecture.

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Wondewell — Bladeless Surgical Trocar Medical Packaging

Wondewell — Surgical Trocar

ISO 11607 • Tyvek®

01. Technical Deliverables

Tyvek® Peelable Pouches & Cartons

Calibrated flexographic or digital imprint files accommodating Tyvek® 1073B/2FS substrate porosity and anti-puncture carton dielines.

ISO 15223-1 Standardized Symbology

Precise vector placement of sterilization indicators (EO, Radiation), single-use icons, temperature storage limits, and lot/expiry tracks.

UDI & Datamatrix GS1 Symbology

Calibrated quiet zones and human-readable interpretation (HRI) typography for 1D and 2D Datamatrix UDI scanners in hospital environments.

Print-Ready Production Files

PDF/X-4 export with clearly separated layers for medical inks, die-cut vectors, and heat-sealing perimeter boundaries.

02. Scope & Validation Boundaries

Monogram Design specializes in graphic architecture, CAD packaging dielines, and prepress artwork. Product claims and regulatory dossiers are supplied and approved by the legal manufacturer.

Regulatory & Validation Notice

Sterile barrier aging studies (ASTM F1980 / ISO 11607-1), clinical IFU validation, and EU MDR 2017/745 or FDA 510(k) notified body submissions remain under the exclusive purview of the legal manufacturer.

Seamless collaboration with R&D engineers, regulatory affairs, and converters.
Harmonized range extensions across multiple French and European device sizes.
Compliant layout of the ISO 15223-1 symbol sequence and UDI placement.
End-to-end technical assistance through prepress and printer proof (BAT) approval.

Associated Case Study

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Wondewell — Bladeless Laparoscopic Surgical Trocar

Comprehensive review of the peelable Tyvek® pouch dieline, sterile barrier layout, and protective folding carton for this Class IIa surgical laparoscopic instrument.

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Work Process

STEP 1 1

Technical Brief & Barrier Specs

Analysis of sterilization methodology (EO, Gamma, V-PRO), thermoformed tray dimensions, and peelable sealing margins.

STEP 2 2

Graphic Layout & ISO Integration

High-contrast artwork drafting, ISO 15223-1 symbol sequencing, and calibrated quiet zones for UDI Datamatrix scanners.

STEP 3 3

Prepress Files & Proof Support

Production PDF/X-4 generation with isolated die/seal lines and technical coordination with medical converters.

Frequently Asked Questions

Do you support UDI (Unique Device Identification) and ISO 15223-1 symbology?

Yes. We integrate the complete sequence of standardized ISO 15223-1 symbols (EO/Radiation sterilization, single-use, temperature limits, non-pyrogenic) alongside calibrated quiet zones for 1D and 2D Datamatrix UDI barcodes.

How do you handle graphic calibration for Tyvek® porous substrates?

Tyvek® has distinct dot gain and ink absorption properties compared to solid bleached sulphate (SBS) boards. We adjust stroke weights, counter spaces in micro-typography, and specify density targets to maintain crisp readability through autoclave or EtO sterilization cycles.

Can you draft folding box dielines for thermoformed blister trays?

Yes. We engineer rigid folding carton dielines designed to immobilize PETG or medical-grade plastic blister trays, preventing puncture, friction, or microbial barrier compromise during logistics.

Do you handle CE MDR certification or FDA 510(k) filing directly?

No. Our studio specializes in packaging design, graphic architecture, and prepress engineering. Physical barrier validation testing (ISO 11607) and regulatory filings are executed by your designated regulatory affairs team and accredited notified body.

Planning a Medical Device Packaging Project?

Consult directly with Ahmed Berbar regarding your sterile barrier and sealing constraints.

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