Your Product Vision.
Our Manufacturing
Expertise.
Transform your healthcare product vision into reality with end-to-end OEM manufacturing solutions — from product development and precision manufacturing to private labeling and global supply.
Specialized OEM Service Pillars
Explore our four core manufacturing and licensing models engineered to deliver clinical precision, regulatory compliance, and scalable global output.
Contract Manufacturing
End-to-end medical device manufacturing from resin formulation, precision extrusion, micro-injection molding to automated cleanroom assembly and sterilization.
Mecca Healthcare provides comprehensive contract manufacturing for global healthcare enterprises, hospitals, and multinational medical device innovators. With 3 world-class production facilities (Kalol, Chhatral, Jodhpur) featuring ISO Class 10,000 (Class 7) & Class 100,000 (Class 8) cleanrooms, we take your conceptual designs or established portfolios and scale them into cost-efficient, high-yield mass production.
Key Engineering & QA Capabilities
- Custom polymer compounding (Medical-grade PVC, DEHP-free PVC, Polycarbonate, PTFE, TPU)
- High-precision multi-lumen tubing extrusion with custom radiopaque barium lines
- Micro-injection molding for specialized connectors, luer locks, drip chambers, and valves
- Automated and semi-automated assembly lines with 100% leak, flow, and tensile testing
- Full batch validation dossiers, Certificates of Analysis (CoA), and audit-ready traceability
Compliance & Quality Guarantee
Every production run at Mecca Healthcare is executed under audited ISO 13485:2016 and WHO-GMP protocols with complete batch documentation and full traceability.
Private Label Manufacturing
Launch market-ready, certified infusion, airway, urology, and surgical disposables under your own proprietary brand identity.
Accelerate your time-to-market without large capital investments in tooling or lengthy regulatory approvals. Our private label program allows healthcare brands and regional distributors to brand Mecca Healthcare’s CE-marked, ISO 13485-certified medical device lines with customized packaging, multilingual Instructions for Use (IFU), and custom color-coded components.
Key Engineering & QA Capabilities
- Complete brand customization: outer carton, inner shelf box, individual sterile peel pouch, and barcode printing
- Custom component color-coding (hub colors, clamp designs, valve grips) matching your product identity
- Multilingual translation and regulatory labeling adhering to EU MDR, US FDA UDI, or local ministry mandates
- Access to established CE Mark technical files and clinical evaluation reports for seamless market import
- Low flexible Minimum Order Quantities (MOQs) for new brand launches and regional market testing
Compliance & Quality Guarantee
Every production run at Mecca Healthcare is executed under audited ISO 13485:2016 and WHO-GMP protocols with complete batch documentation and full traceability.
Loan License Manufacturing
Utilize our CDSCO-approved and WHO-GMP certified cleanroom plants to manufacture your licensed medical device and pharma formulations.
For medical device and pharmaceutical brand owners holding regulatory product licenses (Form MD-5 / MD-9 / Form 28 under CDSCO and international regulatory authorities), Mecca Healthcare offers verified Loan Licensing partnerships. We operate as your audited manufacturing site, maintaining strict standard operating procedures (SOPs), complete documentation, and zero cross-contamination protocols.
Key Engineering & QA Capabilities
- Full regulatory support for license endorsements, site master files (SMF), and dossier submissions
- Dedicated production runs with isolated cleanroom scheduling to prevent cross-contamination
- Comprehensive in-house microbiology, sterility, pyrogen (LAL), and physicochemical testing labs
- Batch manufacturing records (BMR) and batch packaging records (BPR) preserved as per statutory requirements
- Seamless raw material reconciliation and transparent cost modeling
Compliance & Quality Guarantee
Every production run at Mecca Healthcare is executed under audited ISO 13485:2016 and WHO-GMP protocols with complete batch documentation and full traceability.
Custom Packaging & EO Sterilization
Medical-grade Tyvek blister packaging, four-side seal pouching, vacuum packing, and ISO 11135 Ethylene Oxide (EO) sterilization services.
Sterility assurance and packaging integrity are paramount in medical manufacturing. Mecca Healthcare operates automated thermoforming blister packing machines, high-integrity medical paper/film sealing lines, and large-capacity Ethylene Oxide (EO) sterilization chambers validated under ISO 11135 standards with biological indicators (Bacillus atrophaeus) in every cycle.
Key Engineering & QA Capabilities
- Medical-grade DuPont™ Tyvek® and thermoformable clear film blister packing for high-protection devices
- Peelable medical paper/poly pouch sealing with sterile barrier integrity and chevron peel design
- In-house validated EO gas sterilization chambers with automated aeration cycles for low residual ETO/ECH levels
- GS1 barcode, 2D DataMatrix, batch numbering, manufacturing/expiry date thermal transfer printing
- Rigorous seal integrity dye penetration tests, burst pressure testing, and accelerated aging shelf-life validation
Compliance & Quality Guarantee
Every production run at Mecca Healthcare is executed under audited ISO 13485:2016 and WHO-GMP protocols with complete batch documentation and full traceability.
Tailored Engagement Models for Healthcare Brands
Whether you require full turnkey manufacturing, contract packaging, or private label branding, Meca Care delivers compliant solutions designed around your commercial goals.
Private Label Manufacturing
Launch complete medical disposable product lines under your brand identity with custom packaging, color coding, and label specifications.
Turnkey OEM Development
From initial CAD engineering and mold design to cleanroom mass production and sterile packaging under one unified manufacturing roof.
Loan License Manufacturing
Leverage our WHO-GMP and ISO 13485 cleanroom infrastructure to produce your licensed medical device formulations seamlessly.
Contract Packaging & Sterilization
Custom blister packing, pouch sealing, and EO gas sterilization (ISO 11135) services meeting global hospital regulatory standards.
White Label Portfolio
Instant access to market-ready CE & ISO 13485 certified infusion, catheter, and respiratory products with flexible minimum order quantities.
Custom Material & Gauge Specs
Engineered resin options (DEHP-free PVC, silicone, radiopaque PTFE) and bespoke gauge/tubing dimensions tailored to clinical demands.
End-to-End OEM Workflow
Our streamlined 5-step workflow ensures regulatory compliance, strict quality assurance, and predictable delivery timelines for every OEM partnership.
Technical Inquiry & NDA
Review product specifications, CAD drawings, compliance requirements, and execute non-disclosure agreements.
Feasibility & Tooling
Mold assessment, medical grade material selection (DEHP-free PVC, PTFE, silicone), and cleanroom tooling setup.
Pilot Batch & Validation
Trial cleanroom production batch, bio-burden testing, sterilization validation (ISO 11135), and client sign-off.
Mass Cleanroom Production
Scaled automated assembly in Class 100K cleanrooms with 100% inline pressure and visual quality control.
Sterile Packaging & Export
Custom branded blister packaging, export regulatory documentation, and dispatch to 50+ international markets.
World-Class Cleanroom Infrastructure
Meca Care operates modern ISO 13485 cleanrooms equipped with high-speed automated extrusion lines, micro-injection molding machines, and in-house EO sterilization facilities.
Class 100K Cleanrooms
Controlled air filtration & humidity environment
In-House Sterilization
ISO 11135 validated EO gas sterilization chambers
Microbiology Lab
Sterility, pyrogen, and bio-burden testing
Global Regulatory File
CE mark technical dossiers ready for audit
Start Your OEM Project Discussion
Speak directly with our senior medical device engineering team. We review your requirements and respond within 24 hours with technical feasibility feedback and pricing estimates.