Eksmed Limited advised many medical device manufacturers to be compatible with European and local regulations. Our services include:
- Product classification for your medical devices and selection of standards to be applied
- Preparation and review of CE technical and design files
- Ensuring compliance with essential requirements
- Establishment, modification, implementation and development of ISO13485 quality system to ensure compliance with international standards
- Risk assessment and management (ISO 14971)
- Establishment of vigilance and after-sales surveillance systems
Eksmed Limited offers subcontracting manufactruing services to disposable medical devices.
Our team has sufficient knowledge and experience in every process from medical device design to finished product.
We have specific clean room alternatives for medical device solutions. Our ISO 7 clean rooms are fully operated according to GMP and ISO standards. Beside our subcontracting manufacturng services in production, packaging solutions (bag and thermoform packaging), validation studies, EtO sterilization and reporting solutions are used frequently by our customers.
Our services include:
- Turnkey manufacturing solutions
- Subcontracting manufacturing
- Production transfers
- Packaging solutions
- Component assembly
- Ethylene Oxide Sterilization
- Gamma Sterilization
- Packaging Validation
- Gamma Sterilization Validation
- Ethylene Oxide Sterilization Validation
Eksmed Limited provides the registriration services of the medical devices of the companies to the Ministry of Health National Information Database. The collection of necessary information and documents related to the products for registration are completed in a short time. It allows you to bid in the Turkish market without any problem with your products.