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
Accreditations & Certifications
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CEAll Vasmed products are CE certified by the 3EC International Notified BodyRead More -
ISOAll Vasmed facilities are audited and certified by the 3EC International Notified BodyRead More -
GMPAll Vasmed facilities are certified by the UAE Ministry of Health & Prevention CertificationRead More -
SFDAAll Vasmed products have marketing approval in the KSARead More
NOTE: all product certifications have been granted extensions due to the shift from the Medical Device Directive (MDD) to Medical Device Regulation (MDR) enforced by the EU
Extension Letter| Rapstrom Elite | Certification | Design Certification | ||||||
| Notified Body | Certification Number | Download | Notified Body | Certification No. | Download | |||
| 3EC | No. 2019-MDD/QS-056 | Download | 3EC | No. 2019-MDD/DE-057 | Download | |||
| PTCA Accex Guidewire | Certification | Design Certification | ||||||
| Notified Body | Certification Number | Download | Notified Body | Certification No. | Download | |||
| 3EC | No. 2021-MDD/QS-037 | Download | 3EC | No. 2021-MDD/DE-038 | Download | |||
| PTA Indigo Balloon Catheter | Certification | Design Certification | ||||||
| Notified Body | Certification Number | Download | Notified Body | Certification No. | Download | |||
| 3EC | No. 2019-MDD/QS-062 | Download | 3EC | No. 2019-MDD/DE-063 | Download | |||
| Certification | ||
|---|---|---|
| Notified Body | Certification Number | |
| 3EC | EN ISO 13485:2016 | Download |
| Certification | ||
|---|---|---|
| Issuing Body | Certification Number | |
| UAE Ministry of Health & Prevention (UAE MOH) | GMPISS-2025-000041 | Download |
| Rapstrom | Certification | |||
| Issuing Body | Certification Number | Download | ||
| Saudi Food & Drug Authority (SFDA) | MDMA-1-2017-2721 | Download | ||
| PTCA High Track Balloon Catheter | Certification | |||
| Issuing Body | Certification Number | Download | ||
| Saudi Food & Drug Authority (SFDA) | MDMA-1-2019-5447 | Download | ||
| PTCA Vas Track Balloon Catheter | Certification | |||
| Issuing Body | Certification Number | Download | ||
| Saudi Food & Drug Authority (SFDA) | MDMA-1-2019-5447 | Download | ||
| PTA Indigo Balloon Catheter | Certification | |||
| Issuing Body | Certification Number | Download | ||
| Saudi Food & Drug Authority (SFDA) | MDMA-1-2019-5447 | Download | ||
Quality Philosophy/Written Regulatory Compliance
Committed to the design, development, manufacturing, and supply of high-quality cardiovascular medical devices, ensuring compliance with customer, statutory, and regulatory requirements, while continually improving our products and services to enhance customer satisfaction
Continues Improvement
Internal Audits: Conducted twice annually to ensure compliance with quality management systems and internal procedures.
Notified Body Audits: Yearly audits performed by the designated Notified Body to verify conformity with international regulatory standards (e.g., ISO 13485, CE marking requirements).
Regulatory Authority Inspections: Periodic inspections and audits by government agencies, such as the Ministry of Health (UAE), to confirm compliance with national laws and regulations.
Vasmed follows documented procedures for the selection and approval of suppliers as authorized vendors.
Approved suppliers are continuously monitored and re-evaluated on a yearly basis to ensure consistent quality of the materials provided.
The evaluation process includes performance review, compliance with regulatory requirements, and adherence to agreed quality standards.
Vasmed ensures that all nonconformities are documented and tracked through the CAPA system. CAPA activities are reviewed periodically to verify timely implementation of corrective actions. The effectiveness of these actions is evaluated to confirm that the issues are resolved and to prevent recurrence. Preventive measures are also established where applicable to eliminate potential causes of nonconformities.
Vasmed evaluates staff performance on an annual basis to ensure competency in their assigned roles. Employees are assessed, and training is provided to address identified areas for improvement. Yearly training programs are conducted to introduce staff to new technologies and newly implemented standards, ensuring continual enhancement of skills and compliance with regulatory requirements.
Vasmed is committed to identifying and investing in new technologies and equipment to enhance product quality , optimize manufacturing processes, reducing production time, improving efficiency, and minimizing employee workload, thereby fostering a safe and productive work environment.