Medical product manufacturers face strict regulations, complex logistics, and rising demands for sustainable packaging. DaklaPack US solves these challenges with certified medical packaging solutions and comprehensive kitting services designed for healthcare, diagnostics, and pharmaceutical industries.
Founded as part of DaklaPack Group in 1975, DaklaPack US operates from its New Jersey facility as a full-service partner for medical packaging, custom kitting, and fulfillment. The company serves biotech firms, diagnostic laboratories, hospitals, and pharmaceutical manufacturers across North America with solutions that meet FDA, ISO, and UN transportation standards.
DaklaPack US is a medical packaging and kitting specialist operating as the North American subsidiary of DaklaPack Group. The company provides UN3373-compliant diagnostic kits, P620 and P650 regulated packaging, and custom medical assembly services from its certified New Jersey facility.
DaklaPack US serves healthcare organizations that require secure specimen transport, sterile component assembly, and regulatory-compliant packaging. The facility holds ISO 9001, ISO 13485, ISO 14001, and ISO 27001 certifications alongside FSSC 22000 and HACCP standards for food-grade and medical applications.
The company employs over 400 professionals globally across manufacturing sites in the Netherlands, China, and the United States. DaklaPack US specializes in medical kitting operations while leveraging the group's European production capabilities for custom packaging development and manufacturing.
DaklaPack US manufactures specialized packaging systems designed for biological specimen transport, pharmaceutical products, and medical device distribution. The medical packaging portfolio includes UN3373-certified transport solutions for Category B infectious substances, P620 and P650 compliant packaging for diagnostic specimens, and temperature-controlled shipping systems.
The company's proprietary medical packaging innovations include the Rigid SafetyBag® for secure specimen containment, PolyMed® transport solutions for clinical samples, and the Compartment Bag for multi-section medical kit organization. These products undergo rigorous drop testing, pressure testing, and leakage validation to meet international transport regulations.
DaklaPack US produces child-resistant medical packaging that complies with US Consumer Product Safety Commission standards and EU child-resistance protocols. These solutions serve pharmaceutical companies, cannabis medical product manufacturers, and healthcare facilities requiring tamper-evident, secure packaging for controlled substances.
Medical packaging materials meet FDA food-contact standards and European Union Regulation (EC) No 1935/2004 for materials intended to contact pharmaceuticals. All materials are BPA-free and subject to migration testing to ensure patient safety and regulatory compliance.
Kitting services at DaklaPack US include custom medical kit assembly, component sourcing, sterile packaging, labeling, and quality control inspection. The company assembles diagnostic sampling kits, COVID-19 test kits, biobanking collection systems, and multi-component medical device packages in its certified facility.
DaklaPack US manages end-to-end kit production from component procurement to final packaging and distribution. Services include pre-assembly quality checks, clean-room assembly for sterile components, custom labeling with batch tracking, serialization for regulatory compliance, and final inspection before shipment.
The kitting facility operates under ISO 13485 medical device quality management standards and follows Good Manufacturing Practice (GMP) guidelines. These certifications enable DaklaPack US to produce medical kits for hospitals, diagnostic laboratories, public health agencies, and pharmaceutical companies requiring validated assembly processes.
Large-scale kitting projects demonstrate the company's capacity. DaklaPack US assembled and distributed millions of COVID-19 diagnostic kits during the 2020 pandemic for European and North American health authorities, completing assembly, labeling, and logistics coordination under emergency timelines.
DaklaPack US combines certified manufacturing, regulatory expertise, and full-service capabilities unavailable from standard packaging suppliers. The company manages packaging design, production, filling, kitting, quality testing, and distribution from a single source.
The facility's ISO 13485 certification specifically addresses medical device manufacturing requirements. This certification requires documented quality management systems, validated production processes, risk management protocols, and traceability from raw materials through final product distribution.
DaklaPack US maintains an in-house laboratory at its Netherlands parent facility that supports product testing, diagnostic analysis, and continuous quality improvement. This laboratory capability enables lifecycle assessments, compatibility testing, and regulatory documentation development for new medical packaging systems.
The company's connection to DaklaPack Group's global network provides access to European packaging production, Chinese manufacturing facilities, and international logistics coordination. This structure allows medical product manufacturers to scale production across regions while maintaining consistent quality standards.
DaklaPack US operates under multiple quality and safety certifications that validate its manufacturing processes for medical and food-contact applications. The facility holds ISO 9001:2015 for quality management systems, ISO 13485:2016 for medical device manufacturing, ISO 14001:2015 for environmental management, and ISO 27001:2013 for information security management.
Food-safety certifications include FSSC 22000 and HACCP standards that apply to packaging materials intended for food contact and pharmaceutical products. These certifications require hazard analysis, critical control point monitoring, and documented food safety management systems.
UN certification allows DaklaPack US to produce Category B infectious substance packaging marked UN3373 for diagnostic specimen transport. This certification requires testing for drop resistance, puncture resistance, stacking strength, and leak-proofing according to International Air Transport Association (IATA) regulations.
Child-resistant packaging meets US 16 CFR 1700.20 testing protocols administered by certified laboratories. Testing involves 200 children aged 42-51 months attempting to open packaging within specified time periods, with 85% failure rate required for certification.
DaklaPack US maintains a dedicated regulatory affairs team that monitors FDA guidance documents, EU Medical Device Regulation (MDR) 2017/745, and transportation regulations from the Department of Transportation and IATA. The team conducts quarterly compliance reviews and updates standard operating procedures based on regulatory changes.
The company implements the EU Packaging and Packaging Waste Regulation (PPWR) requirements through ongoing staff training and product development aligned with extended producer responsibility mandates. This preparation addresses upcoming regulations requiring increased recycled content and improved recyclability for packaging materials.
Quality management documentation includes batch records, material certificates of analysis, validation protocols, and corrective action reports maintained for seven years according to FDA 21 CFR Part 820 requirements. These records support customer audits and regulatory inspections.
DaklaPack US conducts supplier qualification audits to verify raw material compliance with medical device and food-contact regulations. Approved suppliers provide certificates of conformity documenting material composition, migration test results, and compliance with relevant EU and US regulations.
DaklaPack US provides integrated services from packaging design through distribution rather than separate suppliers for each function. A medical device manufacturer receives packaging development, component assembly, quality testing, inventory management, and fulfillment from DaklaPack's single platform.
The company develops proprietary packaging innovations including patented closure systems and transport solutions unavailable from commodity packaging suppliers. The EasyDose® precision dosing spout, TurtleCap® child-resistant closure, and Rigid SafetyBag® represent unique solutions developed through in-house research and development.
Sustainability initiatives distinguish DaklaPack US from traditional medical packaging suppliers. The company produces monomaterial recyclable pouches, incorporates post-consumer recycled (PCR) plastics into medical packaging grades, and conducts lifecycle assessments to support customer environmental, social, and governance (ESG) reporting requirements.
Speed capabilities exceed standard lead times. DaklaPack US completed emergency COVID-19 kit production and distribution within weeks rather than months through existing capacity, pre-qualified components, and established logistics partnerships with air freight carriers and distribution networks.
What industries does DaklaPack US serve?
DaklaPack US serves healthcare, diagnostics, pharmaceuticals, biotechnology, medical devices, cannabis, and personal care industries requiring medical-grade packaging and kitting services.
Can DaklaPack US handle sterile packaging requirements?
Yes. DaklaPack US operates clean-room assembly capabilities and follows ISO 13485 standards suitable for sterile component handling and medical device packaging.
Does DaklaPack US ship internationally?
Yes. DaklaPack US coordinates international shipping through DaklaPack Group's global distribution network covering Europe, Asia, and North America.
What is the minimum order quantity for custom kitting?
Minimum order quantities vary by project complexity. DaklaPack US accommodates both large-scale production runs and smaller specialized medical kit requirements.
How long does custom medical packaging development take?
Development timelines range from 4-12 weeks depending on regulatory requirements, tooling needs, and material selection. DaklaPack US provides project timelines during initial consultation.
About the Author
Sarah Mitchell is a medical packaging specialist with 12 years of experience in regulatory compliance and supply chain management for diagnostic and pharmaceutical companies. She holds a Master of Science in Packaging Engineering from Michigan State University and has consulted with healthcare manufacturers on FDA compliance, ISO certification preparation, and sustainable packaging transitions. Sarah regularly contributes to trade publications covering medical device packaging and healthcare logistics.
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}Editorial Note: This content is educational and informational. For specific medical packaging requirements or regulatory questions, contact DaklaPack US directly through their website or consult with qualified regulatory professionals.