Manufacturing excellence for
life-saving cardiovascular implants
State-of-the-art cleanrooms, validated processes and uncompromising quality systems designed to meet global regulatory expectations for Class III medical devices.
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State-of-the-art medical device manufacturing facility commissioned in February 2023.
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Total built-up area of 50,000 sqft.
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Designed areas for manufacturing, storage, sterilization, administration, etc.
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Manufacturing area consists of clean rooms with ISO Class 10,000 classification. The clean rooms are validated as per the ISO 11104 standard.
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All storage and intermediary work areas are maintained in controlled areas.
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State-of-the-art equipment calibrated as per standards.
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Clear work instructions, QC directives & process flowcharts.
- UAE MOH Good Manufacturing Practices Certified Facilities
- Total Production Area: 20,000 sqft.
- Trained and skilled manpower with 20+ years of experience in product manufacturing
- ISO 13485:2016 compliant Quality Management System to ensure all process and controlled and measured for continuous improvement
- ISO Class 10,000 classified cleanrooms, validated as per ISO 11104 standards to ISO 14644-1 standards
- State-of-the-art equipment calibrated as per standards
- ISO 11135:2014 certified ETO sterilization facilities
certifications & accreditations
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GMPAll Vasmed facilities are certified by theRead More
UAE Ministry of Health & Prevention Certification -
ISOAll Vasmed facilities are audited and certified by theRead More
3EC International Notified Body
| Certification | ||
|---|---|---|
| Issuing Body | Certification Number | |
| UAE Ministry of Health & Prevention (UAE MOH) | GMPISS-2025-000041 | Download |
| Certification | ||
|---|---|---|
| Notified Body | Certification Number | |
| 3EC | EN ISO 13485:2016 | Download |
- Specifications established during design and development. Ensuring consistent quality and suitability for the intended use
- Biocompatible specificity in accordance with ISO 10993 standards for biological evaluation of medical devices. USP Class VI certified materials ensuring that the material passes stringent requirements for systemic toxicity, intracutaneous reactivity, and implantation effects
- Traceablility to the source is maintained and accompanied by a Certificate of Analysis (CoA)
Balloon Forming Using Machines
Balloon forming is carried out using balloon forming machines, which employ precision blow molding in controlled molds. Heat and pressure are applied to extruded tubing to shape the balloon, followed by stretching to orient polymer chains and enhance strength, elasticity, and performance. This controlled process ensures uniform wall thickness, high dimensional accuracy, and reliable functional characteristics essential for stent delivery systems and catheters.
Bonding & Tipping Using Welding Machines
Our welding machines enable precise bonding and tipping of catheters and balloons without adhesives. Balloons are fused directly to the outer and inner lumens, and the lumen is accurately welded to the hub tube. Special attention is given to the transition point weld, ensuring perfect alignment of the lumens, maintaining inner diameter, and guaranteeing smooth guidewire passage and fluid flow. This process ensures structural integrity, reliable performance, and consistent device quality.
Balloon Folding Using Folding Machines
Specialized balloon folding machines are used to precisely fold balloons for stent delivery systems and PTCA balloon Catheter. The balloon is partially collapsed using vacuum and mechanical compression to create a tri-fold configuration (three wings). It is then carefully wrapped around the catheter shaft, reducing the overall crossing profile and ensuring a compact, consistent, and reliable design for safe and effective delivery.
Stent Coating Process Using Spray Technology
Our stent coating process utilizes advanced spray technology to achieve precise and uniform application of polymer and drug layers on stents. This method ensures consistent coating thickness, excellent adhesion, and controlled drug release profiles.
Stent Crimping Using MSI Machines
We employ state-of-the-art MSI stent crimping machines to precisely mount stents onto balloon catheters. These systems ensure uniform radial compression, accurate positioning, and secure stent retention without damaging the balloon or coating. With programmable control of crimping force, diameter, and cycle steps, MSI technology provides superior repeatability and reliability. This enables us to achieve tight dimensional tolerances and consistent product performance, meeting the highest quality and regulatory standards.
Ethylene Oxide (ETO) sterilization
Ensuring complete microbial inactivation while preserving the functionality, material integrity, and performance of the sterilized medical devices. The process is compliant with ISO 11135:2014.
At Vasmed Technologies, we ensure every catheter and stent meets the highest standards of safety, performance, and reliability. All tests are performed in accordance with ISO 10555, ISO 25539, and ISO 10993 standards
Catheter Testing
Our PTCA catheters undergo rigorous mechanical evaluations to ensure superior clinical performance:
- Tensile & Bond Strength – Confirms structural integrity under pull forces.
- Burst & Leak Pressure – Ensures lumen and balloon integrity under pressure.
- Flexibility & Kink Resistance – Verifies smooth navigation through tortuous anatomy.
- Pushability, Trackability & Torquability – Confirms precise control and delivery.
- Dimensional Accuracy & Flow – Ensures compatibility with guidewires and consistent fluid delivery.
Stent Testing
All stent systems are tested as per ISO 25539 for mechanical reliability:
- Stent Retention & Radial Force – Ensures secure mounting and vessel support.
- Foreshortening & Recoil – Verifies accurate expansion and dimensional stability.
- RBP & Flexibility Tests – Confirms safe balloon inflation and smooth delivery.
- Trackability & Crossability – Ensures ease of navigation through complex vessels.
Drug-Eluting Stent (DES) Testing
Our DES undergo comprehensive drug evaluations to ensure controlled and consistent therapeutic delivery:
- Drug Content & Assay – Validates correct dosage and purity.
- Drug Release (Elution) – Confirms sustained, predictable release under physiological conditions.
Shelf-Life Studies
Both Accelerated and Real-Time Aging studies (ASTM F1980, ISO 11607-1) verify long-term product safety and performance.
Biocompatibility
All Vasmed products are tested per ISO 10993 for biological safety, including:
- Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Genotoxicity, and Hemocompatibility.
These evaluations ensure full compatibility and patient safety during clinical use.
The following tests are mandatorily carried out prior to batch release:
- High-Performance Liquid Chromatography (HPLC)
- High-Performance Liquid Chromatography (HPLC)
- Tensile & Bond Strength
- Burst & Leak Pressure
- Dimensional Accuracy & Flow
- Stent Retention
- Drug Content & Assay
- Drug Release (Elution)