Medical Device Contract Packaging
Written by
Arterex Medical
Published on
January 05 , 2026
Read time
20 minute read
Arterex Medical is a medical device manufacturer providing medical device packaging services that ensure products reach healthcare providers in sterile, protected conditions while meeting rigorous regulatory standards governing global distribution. Our specialized contract packaging protects devices from contamination, physical damage, and environmental factors throughout manufacturing, sterilization, storage, and clinical use.
We deliver comprehensive packaging services for medical device manufacturers requiring ISO-certified cleanroom environments, validated sterile barrier systems, and regulatory-compliant documentation. Our expertise spans simple single-use devices to complex surgical kits requiring multiple components, custom configurations, and stringent traceability requirements.
Contract packaging partners provide manufacturers with critical advantages including reduced capital investment in specialized equipment, access to validated processes and regulatory expertise, scalable production capacity that adjusts to demand fluctuations, and accelerated time to market through established quality systems. These benefits allow device companies to focus resources on product innovation and commercialization while experienced packaging specialists handle compliance complexities.
Our facilities operate under FDA Quality System Regulations and ISO 13485 standards with Class 7 and Class 8 cleanrooms designed specifically for medical device assembly and packaging. We manage every aspect from initial design consultation and material sourcing through prototype validation, production manufacturing, sterilization coordination, and distribution logistics.
Arterex Medical serves diverse device categories including surgical instruments, implantable products, diagnostic equipment, and combination products requiring pharmaceutical-grade packaging. Our capabilities encompass sterile pouches, thermoformed trays, blister packaging, kit assembly, UDI labeling, and secondary packaging with complete validation documentation that supports regulatory submissions worldwide.
This comprehensive approach delivers packaging solutions that protect patient safety, ensure regulatory compliance, and support commercial success throughout the medical device lifecycle.
What Types of Medical Device Packaging Do We Offer?
The types of medical device packaging we offer are listed below:
Cleanroom packaging services performed in ISO-certified Class 7 and Class 8 controlled environments ensure particulate-free assembly for medical devices requiring contamination control before sterilization, utilizing validated procedures that minimize bioburden, prevent foreign material introduction, and maintain documented environmental monitoring that supports regulatory submissions, quality audits, and compliance with Good Manufacturing Practice standards for sensitive implantable and surgical products.
Our sterile barrier systems include Tyvek pouches, medical-grade foil pouches, and chevron-style peel pouches that maintain aseptic conditions from manufacturing through clinical use while meeting ISO 11607 standards for sterile medical device packaging, ensuring product integrity, preventing microbial contamination, and supporting ethylene oxide, gamma radiation, or steam sterilization validation processes.
Blister and pouch packaging solutions combine PVC, PETG, or polystyrene forming films with medical-grade lidding materials and heat-sealed pouches to create tamper-evident, moisture-resistant enclosures ideal for single-use devices, diagnostic test kits, and pharmaceutical-device combination products, offering child-resistant designs, senior-friendly openings, and compatibility with automated filling lines that enhance production efficiency while maintaining hermetic seals.
Custom trays and clamshell packaging feature precision-molded cavity configurations designed to secure devices during transport and storage, preventing movement damage while accommodating specific product geometries ranging from surgical instruments to implantable components, with options for clear PETG material that enables visual inspection or opaque materials that provide light protection for photosensitive devices requiring enhanced barrier properties.
Kit assembly and labeling services consolidate multiple components—including instructions for use, accessories, sterile devices, and ancillary supplies—into procedure-specific configurations with accurate product labeling that streamlines clinical workflows, reduces operating room setup time, eliminates component selection errors, ensures regulatory compliance, and provides clinicians with complete, properly identified, ready-to-use systems that improve surgical efficiency and enhance patient safety.
UDI and regulatory labeling services incorporate Unique Device Identification barcodes, lot numbers, expiration dates, and manufacturer information that comply with FDA 21 CFR Part 801 requirements, EU Medical Device Regulation standards, and global harmonization guidelines, utilizing GS1-compliant formatting, automated verification systems, and serialization capabilities that enable traceability, post-market surveillance, recall management, and supply chain transparency throughout distribution networks.
Secondary and tertiary packaging including printed cartons, shipper boxes, corrugated cases, and protective outer packaging display regulatory markings, provide product identification through high-resolution graphics, ensure compliance with international shipping standards, incorporate tamper-evident seals, and offer structural protection that safeguards primary sterile packaging during warehousing, transportation, and distribution while communicating essential information to healthcare providers and logistics partners.
Packaging for sterilization supports ethylene oxide (ETO), gamma radiation, and steam autoclave processes using validated materials like Tyvek, medical-grade papers, and breathable films that permit sterilant penetration while maintaining sterile barrier integrity, with material compatibility testing, sterilization cycle validation documentation, and packaging designs that accommodate residual gas dissipation requirements, radiation dosimetry specifications, and high-temperature steam exposure without compromising seal strength or barrier performance.
Controlled environment packaging for moisture-sensitive electronics integrates desiccant packets, humidity indicator cards, and moisture barrier films within sealed configurations that maintain specified relative humidity levels, prevent corrosion of electronic components, protect sensitive circuitry from environmental degradation, and extend shelf life for diagnostic equipment, powered surgical instruments, and implantable electronic devices requiring strict environmental controls.
Custom cushioning systems using die-cut foam, molded pulp, or engineered corrugated inserts absorb shock and vibration during global distribution networks, provide impact protection that prevents device damage during handling incidents, accommodate fragile components with precision-cut cavities, and undergo drop testing validation to ensure products survive ISTA-certified transit scenarios from manufacturing facilities to end-user destinations worldwide.
What Is Our Process for Medical Device Packaging?
Our process for medical device packaging are listed below:
1. Initial Consultation and Requirements Assessment
We start by understanding your device specifications, regulatory requirements, and market needs. Our team evaluates device dimensions, material sensitivity, sterilization methods, and distribution environments to recommend the right packaging solution. This assessment identifies critical protection needs, compliance standards, and cost optimization opportunities for your specific product.
2. Design and Engineering
Our engineers create custom packaging designs using CAD modeling and finite element analysis. We select materials based on barrier properties, sterilization compatibility, and mechanical strength requirements. The design phase balances protection performance with manufacturing efficiency while ensuring the package integrates smoothly with your production workflow.
3. Material Selection and Sourcing
We source FDA-compliant materials from qualified suppliers with full documentation and certifications. Materials are chosen for sterilization resistance, seal integrity, shelf life stability, and barrier effectiveness. Every material undergoes incoming inspection to verify it meets medical-grade specifications before entering our cleanroom facilities.
4. Prototype Development
Prototypes are built to exact specifications and tested under real-world conditions. We create samples that allow you to evaluate fit, function, and appearance before committing to production tooling. This stage confirms the design meets both technical requirements and practical handling needs for end users.
5. Validation and Testing
Packages undergo comprehensive testing including seal strength analysis, package integrity verification, and accelerated aging studies per ASTM F1980 and ISO 11607 standards. We perform sterile barrier testing, distribution simulation, and environmental conditioning to validate performance throughout the product lifecycle. Test protocols are documented with complete data packages for regulatory submissions.
6. Regulatory Documentation
Our quality team prepares validation reports, packaging specifications, and compliance documentation that support FDA submissions and international registrations. We provide material certificates, biocompatibility summaries, and sterilization compatibility data. All documentation follows FDA Quality System Regulations and ISO 13485 requirements with full traceability.
7. Production Setup and Qualification
Production lines are configured with validated equipment, trained operators, and documented procedures. We conduct installation qualification, operational qualification, and performance qualification to verify consistent output. Environmental monitoring ensures cleanroom conditions meet ISO 14644 classifications throughout manufacturing operations.
8. Manufacturing and Quality Control
Production runs in controlled environments with continuous monitoring and in-process inspections. Automated vision systems check seal quality, package integrity, and dimensional accuracy. Statistical process control tracks critical parameters to detect variations immediately and maintain validated conditions across all production batches.
9. Sterilization Compatibility Verification
Packages are tested before and after sterilization exposure to confirm material stability and barrier performance. We validate compatibility with ethylene oxide, gamma radiation, and steam sterilization through accelerated aging and package integrity testing. This ensures sterile barrier properties remain intact through sterilization cycles and required aeration periods.
10. Labeling and Serialization
Regulatory labels are applied using validated printing systems with barcode verification and quality checks. We integrate UDI compliance, lot tracking, expiration dating, and serialization per FDA and GS1 standards. Automated verification prevents labeling errors and ensures 100% accuracy for traceability and recall management.
11. Final Inspection and Documentation
Regulatory labels are applied using validated printing systems with barcode verification and quality checks. We integrate UDI compliance, lot tracking, expiration dating, and serialization per FDA and GS1 standards. Automated verification prevents labeling errors and ensures 100% accuracy for traceability and recall management.
12. Packaging and Distribution
Finished packages are packed in protective shipping containers with proper labeling and handling instructions. We coordinate delivery to your facilities, distribution centers, or sterilization vendors with chain of custody documentation. Our logistics ensure packages arrive in validated condition ready for the next manufacturing step.
13. Ongoing Support and Optimization
We provide continuous technical support for packaging performance questions, regulatory updates, and process improvements. Our team monitors industry changes, conducts periodic package reviews, and recommends design updates when regulations evolve or market requirements change. This partnership approach ensures your packaging remains compliant and effective throughout the product lifecycle.
Why Choose Arterex Medical for Medical Device Packaging Services?
Arterex Medical delivers precision-driven, fully compliant medical device packaging solutions backed by advanced technologies, rigorous quality systems, and deep regulatory expertise. Our comprehensive capabilities ensure your products move efficiently from concept to commercial distribution with uncompromising safety, sterility, and reliability.
ISO-Certified Cleanroom Facilities
Our ISO 13485-certified facilities operate Class 7 and Class 8 cleanrooms with validated environmental controls that maintain particulate limits, temperature stability, and humidity specifications required for medical device packaging. Continuous monitoring systems track air quality, pressure differentials, and bioburden levels to ensure every package meets sterility and contamination control standards from assembly through final inspection.
Comprehensive Regulatory Expertise
We navigate FDA regulations, ISO 11607 standards, and international compliance requirements with deep knowledge of medical device classifications, UDI mandates, and sterilization validation protocols. Our regulatory team prepares submission-ready documentation including design verification reports, package validation studies, and material biocompatibility data that accelerate approval timelines and satisfy auditor requirements across global markets.
Full-Service Packaging Solutions
Arterex Medical provides end-to-end services from initial design consultation through production, sterilization coordination, labeling, and distribution management. This integrated approach eliminates multiple vendor coordination, reduces lead times, and ensures seamless transitions between packaging stages. We handle everything so you can focus on device development and market expansion.
Advanced Testing and Validation Capabilities
Our on-site testing laboratory performs seal strength analysis, package integrity testing, accelerated aging studies, and distribution simulation per ASTM and ISO standards. We conduct real-time and accelerated shelf life studies, sterile barrier validation, and sterilization compatibility testing with documented protocols that provide the evidence needed for regulatory submissions and quality system compliance.
Customized Design Engineering
Our engineering team creates packaging solutions tailored to your device’s unique requirements including complex geometries, fragile components, and multi-part assemblies. We use CAD modeling, prototyping iterations, and design for manufacturing principles to optimize material efficiency, reduce costs, and improve production speed while maintaining protection performance and regulatory compliance.
Sterilization Method Compatibility
Our packaging designs accommodate ethylene oxide, gamma radiation, electron beam, and steam sterilization with validated material selections and testing protocols. We understand sterilization cycle parameters, aeration requirements, and material degradation factors to ensure packages maintain integrity and performance throughout sterilization processing without compromising sterile barrier properties or device functionality.
Scalable Production Capacity
We support projects from small pilot runs to high-volume commercial production with flexible manufacturing capabilities that scale with your business growth. Our production planning accommodates demand fluctuations, rush orders, and product launches without compromising quality standards. This scalability gives you reliable supply continuity from clinical trials through full market distribution.
Material Sourcing and Supply Chain Management
Arterex Medical maintains relationships with qualified suppliers of medical-grade materials and manages procurement, inventory, and quality verification. We ensure material traceability with certificates of conformance, conduct incoming inspections, and maintain safety stock to prevent production delays. Our supply chain expertise protects you from material shortages and quality issues.
Our Certifications for Medical Device Packaging
ISO 13485:2016 Certification
Arterex Medical maintains ISO 13485:2016 certification, demonstrating our quality management system meets international standards for medical device manufacturing and packaging services.
FDA Registration and Compliance
Our facilities are FDA-registered and operate under 21 CFR Part 820 Quality System Regulations for medical device contract manufacturing compliance.
ISO 14644 Cleanroom Classification
Our cleanrooms meet ISO 14644-1 standards with validated Class 7 and Class 8 environments for contamination-controlled medical device packaging assembly.
Good Manufacturing Practice (GMP) Compliance
We follow GMP standards ensuring documented procedures, validated processes, and quality controls for pharmaceutical-grade medical device packaging and combination products.
ISO 11607 Packaging Validation
Our packaging processes comply with ISO 11607 standards for terminally sterilized medical devices, including integrity testing and sterile barrier validation.
ASTM Testing Standards Compliance
We perform testing per ASTM standards including F1980 for aging, F88 for seals, and F2095 for integrity verification.
GS1 Standards for UDI and Serialization
We implement GS1 global standards for Unique Device Identification, barcoding, and serialization meeting FDA and EU regulatory traceability requirements.
Medical Device Single Audit Program (MDSAP)
Our quality system aligns with MDSAP requirements, harmonizing regulatory compliance across United States, Canada, Brazil, Japan, and Australia markets.
Environmental and Safety Certifications
We maintain environmental management and OSHA workplace safety certifications supporting sustainable operations and employee protection in medical device manufacturing.