OEM Medical Device Manufacturing: Precision Engineering & Global Sourcing Portal

We supply a comprehensive technical documentation dossier formatted according to STED (Summary Technical Documentation) guidelines to support swift product registration with national health authorities (such as EU MDR, US FDA, ANVISA, SFDA, and MOH). Each OEM shipment includes:

• • ISO 13485:2016 Quality Management Certificate and CE Certificate of Conformity
• • EC Declaration of Conformity and Certificate of Free Sale (CFS)
• • ISO 10993 Biocompatibility test reports (Cytotoxicity, Sensitisation, Systemic Toxicity, Hemocompatibility)
• • Ethylene Oxide (EO) Sterilisation Validation Reports per EN ISO 11135 and EO residue reports per ISO 10993-7
• • Batch-specific Certificate of Analysis (CoA) detailing physical dimensions, flow rate, particulate cleanliness, and sterility release

Our OEM packaging infrastructure supports complete private-label customisation. We print your brand logo, corporate artwork, product catalog numbers, and country-specific translations directly onto medical-grade paper/film blister pouches, shelf boxes, and shipping cartons. Furthermore, our packaging lines feature GS1-compliant 2D DataMatrix printing for Unique Device Identification (UDI), ensuring full compliance with EUDAMED and US FDA GUDID tracking mandates.

MOQs depend on whether the product utilizes standard componentry with custom private-label packaging or requires custom tool development:

• • Private-Label Standard SKUs: MOQ typically ranges from 50,000 to 100,000 units per SKU (equivalent to primary print run limits for medical blister film).
• • Custom Tooling / Modified Components: Determined based on mould cavity count and resin run size.
• • Production Lead Times: Repeat private-label orders ship within 3 to 4 weeks post artwork approval. First-time OEM projects require 5 to 7 weeks to allow for packaging proofing, trial moulding, and EO sterilisation validation.

Yes. All our IV cannulas, safety catheters, three-way stopcocks, extension lines, IV infusion sets, and burette sets can be produced using 100% DEHP-free PVC, Polyurethane (PUR), or Thermoplastic Elastomer (TPE) compounds. All component elastomers (flashbulbs, injection sites, septa) are guaranteed latex-free to prevent adverse allergic reactions during clinical administration.

To eliminate leakage risks, 100% of manufactured three-way stopcocks undergo automated positive-pressure air decay leak testing at 4.5 bar (65 psi) before cleanroom packaging. Additionally, critical male/female Luer connectors are manufactured strictly according to ISO 80369-7 dimensions to guarantee leak-tight, standardized connections with all international Luer-taper medical devices.

Device assembly takes place inside state-of-the-art ISO Class 8 cleanrooms equipped with positive differential pressure and continuous HEPA filtration. Airborne particulate counts, settling plates, and surface bioburden levels are sampled daily by our microbiology laboratory. Prior to Ethylene Oxide sterilisation, product bioburden is rigorously quantified to ensure sterility assurance levels (SAL 10⁻⁶) are reliably achieved.

We offer flexible commercial terms adapted to international trade practices:

• • Incoterms: FOB (Nhava Sheva / Mundra Port), CIF (Destination Port), or DDP (Delivered Duty Paid to client warehouse).
• • Air Freight: Direct dispatch via Indira Gandhi International Airport (DEL), New Delhi.
• • Consolidation: Full Container Loads (FCL 20ft/40ft HQ) or Less than Container Loads (LCL) consolidated directly at our Sonepat plant.
• • Payment Methods: Confirmed Irrevocable Letter of Credit (L/C at sight), Wire Transfer (T/T), or structured trade credit for long-term contract partners.

You can start by sharing your product specifications, target drawing files, gauge requirements, or current sample reference with our engineering desk. Click the Contact Us link to open a direct inquiry window. Evaluation samples with comprehensive test reports are dispatched via express courier within 3 to 5 business days.