Medical Device Manufacturing
UTAKSIS provides easy-to-use solutions for products manufactured in the medical device and medical sector. It can easily meet the traceability and auditability needs of products that need to be manufactured within the scope of ISO-13485.
Starting with the number given to the product to be manufactured at the raw material input, it provides the opportunity to easily track and monitor some processes specific to the medical device sector. Since implants that can be placed in the body are subject to gamma radiation, it provides the opportunity to track the relevant process and gamma certificate information.
Thanks to the integration with UTS (Product Tracking System), which is developed by the Ministry of Health and is an e-Government application, it offers solutions not only for manufacturers but also for importer companies. In the UTS system, after the registration process of all products produced or imported, production or import notifications along with giving and receiving notifications are frequently used.
UTAKSIS, which prevents user-based errors during this process, allows you to manage the process quickly, regularly and error-free by using the FIFO (first in, first out) method.
Medical Sector Specific Features
ISO 13485 Compliance
Process management and documentation system fully compliant with the medical device quality management system standard.
Full Traceability
Complete traceability from raw materials to final products. Lot tracking, serial number management and recall support.
Sterilization Tracking
Tracking of gamma ray, ETO and other sterilization methods. Management and archiving of sterilization certificates.
UTS Integration
Full integration with Ministry of Health UTS system. Automatic notifications, production and import records.
Quality Control
Quality control processes specific to medical devices. Test results, calibration records and validation documentation.
Regulatory Compliance
Documentation and reporting system compliant with MDR, FDA and other regulatory authority requirements.
Implant Management
Special tracking system for implants that can be placed in the body. UDI (Unique Device Identification) support.
Risk Management
Risk analysis and management compliant with ISO 14971 standard. CAPA (Corrective and Preventive Actions) system.
Clinical Data Management
Management of clinical evaluation and post-market surveillance data. Adverse event reporting system.
Regulations and Standards
MDR (Medical Device Regulation)
Full compliance with European Union Medical Device Regulation requirements. CE marking processes and technical documentation management.
FDA 21 CFR Part 820
Process management and record keeping system compliant with United States FDA quality system regulations.
ISO 13485:2016
Full compliance with quality management system standard for medical devices. Continuous improvement and risk-based approach.
UTS System
Full integration with Turkey Ministry of Health Product Tracking System. Automatic notifications and e-Government compliance.
UTAKSIS Advantages in Medical Sector
- Fast Audit Preparation: Instant access to all necessary documentation and records in audit processes
- Recall Management: Quick identification of affected products in critical situations and management of recall process
- Cost Optimization: Optimization of costs through inventory management and production planning
- Quality Assurance: Guaranteeing product quality through continuous quality control and improvement processes
- Fast Market Entry: Faster delivery of new products to market by accelerating regulatory processes
- Risk Reduction: Early detection of potential problems through proactive risk management
Digital Transformation in Medical Sector
Realize your digital transformation in the medical sector with UTAKSIS. Contact us for regulatory compliance, quality assurance and operational efficiency.