Quality & Certifications
Commitment to excellence in medical device manufacturing
Quality Policy
Desmo Care is committed to delivering surgical sutures and wound closure solutions of the highest quality that meet or exceed customer expectations and regulatory requirements.
Our Quality Commitments
- ✓Maintain ISO 13485:2016 certified quality management systems across all manufacturing operations
- ✓Ensure full compliance with EU Medical Device Regulation (MDR) 2017/745 and all applicable international standards
- ✓Implement rigorous quality control at every stage from raw material selection through final product release
- ✓Foster a culture of continuous improvement through systematic monitoring, measurement, and corrective action
- ✓Provide safe, effective medical devices that support positive patient outcomes
- ✓Maintain transparent post-market surveillance and product vigilance systems
- ✓Invest in employee training and development to ensure competence at all levels
- ✓Partner with healthcare professionals to understand and address evolving clinical needs
This quality policy is communicated throughout the organization and reviewed annually to ensure its continuing suitability.
Certifications
ISO 13485:2016
Medical Devices Quality Management
Certified quality management system specifically designed for medical device manufacturers, ensuring consistent design, development, production, and delivery of medical devices.
Scope: Design, manufacture, and distribution of surgical sutures and wound closure devices
Standard: ISO 13485:2016
CE Marking
EU MDR 2017/745 Compliance
CE marking demonstrates conformity with the requirements of the Medical Device Regulation (EU) 2017/745, indicating that our medical devices meet high safety, health, and environmental protection requirements.
Regulation: EU MDR 2017/745
Classification: Class I / Class IIa
Scope: Surgical sutures and wound closure devices
Regional Compliance
European Union
- ✓ MDR 2017/745 Compliant
- ✓ CE Marked Products
- ✓ Notified Body Approved
- ✓ EUDAMED Registration
- ✓ EU Authorized Representative
United States (Export)
- ✓ ISO 13485 Quality System (harmonized with 21 CFR Part 820 principles)
- ✓ UDI Implementation
- ✓ Full Traceability Documentation
- ✓ Regulatory Support for US Market Access
Middle East & Others
- ✓ SFDA (Saudi Arabia) Approved
- ✓ MOHAP (UAE) Registered
- ✓ GCC Countries Compliant
- ✓ Local Representatives
- ✓ Arabic Documentation
Manufacturing Excellence
20,000
m² Production Facility
100+
Employees
30+
Years of Heritage
80+
Countries Served
Our 20,000 m² production facility in Çerkezköy OSB, Tekirdağ, Turkey carries over 30 years of medical device manufacturing heritage, dating back to 1993 as SSM Sutures. Today, more than 100 employees work across vertically integrated production lines to deliver surgical sutures and wound closure solutions to healthcare providers in over 80 countries.
State-of-the-Art Facilities
- •ISO Class 7 and Class 8 cleanroom environments for sterile manufacturing
- •Validated manufacturing processes with continuous monitoring
- •Automated quality control and optical inspection systems
- •Environmental monitoring and HVAC control systems
Sterilization & Quality Assurance
- •In-house EO (Ethylene Oxide) and Gamma irradiation sterilization capabilities
- •100% product inspection protocols with full batch traceability
- •Regular third-party audits and inspections by notified bodies
- •Continuous improvement programs (CAPA) and post-market surveillance
Standards Compliance
ISO 13485:2016
Medical Device QMS
ISO 9001
Quality Management
USP Standards
US Pharmacopeia
EP Standards
European Pharmacopoeia
ISO 11137
Sterilization Validation
ISO 11607
Packaging Requirements
ISO 10993
Biological Evaluation
ISO 14971
Risk Management
EN 13795
Surgical Drapes & Gowns
Quality & Regulatory Inquiries
For questions about our quality management system, certifications, or regulatory compliance:
Email: info@desmocare.com
Quality Department: info@desmocare.com
General Inquiries: info@desmocare.com