MedPack Pro
ISO 13485 Certified Medical Packaging

Precision Packaging
for Medical Excellence

We engineer sterile, compliant, and sustainable packaging solutions that protect life-saving medical devices and pharmaceuticals — from production line to patient care.

0+ Medical Products Packed
0% Sterility Assurance
0+ Countries Served

Trusted by Leading Healthcare Brands

For over two decades, MedPack Pro has been at the forefront of medical packaging innovation, combining cutting-edge technology with rigorous quality standards.

Our Mission

To deliver world-class medical packaging solutions that safeguard patient health and enable healthcare innovation across the globe.

20+ Years

Two decades of expertise in designing, testing, and manufacturing packaging systems that meet the strictest regulatory requirements.

FDA & CE Compliant

Every packaging solution fully complies with FDA 21 CFR, EU MDR, ISO 11607, and ISO 13485 standards for maximum patient safety.

Quality First

Rigorous quality control at every stage — from material sourcing to final seal integrity testing — guarantees flawless deliveries.

Medical Packaging Solutions

Comprehensive packaging systems designed for surgical instruments, implants, pharmaceuticals, and diagnostic devices.

Sterile Barrier

Tyvek® Peel Pouches

High-density polyethylene pouches providing superior microbial barrier and easy aseptic presentation for surgical instruments.

EtO Compatible Peel Seal ISO 11607
Sterile Barrier

Header Bag Systems

Chevron or straight-seal header bags with integrated hanging features, ideal for orthopedic implants and surgical kits.

Gamma Safe Clear Panels Custom Sizes
Pharma

Blister Packaging

Thermoformed blister packs with foil or Tyvek® lids, designed for unit-dose pharmaceuticals with tamper-evident features.

Child-Resistant Tamper-Evident Moisture Barrier
Device

Form-Fit Trays

Custom thermoformed PETG and HIPS trays with precision-molded cavities that secure delicate medical devices during transit.

Custom Mold Shock Absorb Stackable
Custom

Kitting & Assembly

End-to-end custom kitting solutions — multi-component surgical kits assembled, sealed, and labeled in ISO Class 7 cleanrooms.

Cleanroom Labeling Full Kitting
Pharma

Cold Chain Packaging

Temperature-controlled packaging with insulated liners and phase-change materials for biologics and vaccines requiring 2–8°C.

2–8°C Range 72hr Hold Validated

End-to-End Services

From concept to market — we provide comprehensive packaging engineering, testing, and manufacturing services.

01

Package Design & Engineering

CAD-driven packaging design with FEA simulation, material selection consulting, and design for manufacturability optimization.

02

Validation & Testing

ASTM & ISTA protocol testing — seal strength, burst, dye penetration, accelerated aging, and distribution simulation.

03

Regulatory Compliance

Full regulatory support for FDA 510(k), EU MDR, and global submissions including DHF documentation and technical files.

04

Cleanroom Manufacturing

ISO Class 7 & 8 cleanroom facilities with automated form-fill-seal, pouch sealing, and labeling lines for sterile packaging.

05

Sterilization Compatibility

Packaging validated for EtO, gamma, e-beam, and steam sterilization methods with full IQ/OQ/PQ documentation.

06

Global Logistics

Worldwide distribution support with validated shipping containers, temperature-monitored transport, and track-and-trace systems.

Our Proven Process

A systematic, FDA-validated workflow that takes your medical product from concept to market with complete confidence.

1

Discovery & Consultation

We analyze your product dimensions, material compatibility, sterilization method, and regulatory pathway to define optimal packaging requirements.

2

Design & Prototyping

Our engineers create 3D CAD models, run simulations, and produce rapid prototypes for functional evaluation and stakeholder review.

3

Validation & Testing

Complete IQ/OQ/PQ protocols with accelerated aging, transit testing, sterile barrier integrity, and seal-strength verification per ISO 11607.

4

Regulatory Submission

We compile all documentation — test reports, material certifications, and stability data — for your regulatory filing.

5

Production & Delivery

Cleanroom manufacturing at scale with automated quality inspection, lot traceability, and on-time delivery to your facility worldwide.

Industry Recognition

🏥

ISO 13485:2016

Certified Quality Management System for Medical Devices

🛡️

FDA Registered

Registered Facility under 21 CFR Part 820

🌍

CE Marked

EU MDR 2017/745 Compliant Packaging Solutions

♻️

Sustainable

Eco-Friendly Materials & Carbon Neutral Operations

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