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.
Certificate No: [To be added]
Issued by: [Certification Body]
Valid until: [Date]
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.
Notified Body: [Name and Number]
Classification: Class I / Class II
Certificate No: [Number]
GMP Certified
Good Manufacturing Practices
Compliance with Good Manufacturing Practices ensures systematic quality approach in production, including proper facilities, equipment, procedures, and personnel training.
Standards: WHO GMP, EU GMP
Scope: Medical device manufacturing
Regional Compliance
European Union
- ✓ MDR 2017/745 Compliant
- ✓ CE Marked Products
- ✓ Notified Body Approved
- ✓ EUDAMED Registration
- ✓ EU Authorized Representative
United States
- ✓ UDI Implementation
- ✓ Quality System Standards
- ✓ Medical Device Safety
Middle East & Others
- ✓ SFDA (Saudi Arabia) Approved
- ✓ MOHAP (UAE) Registered
- ✓ GCC Countries Compliant
- ✓ Local Representatives
- ✓ Arabic Documentation
Manufacturing Excellence
State-of-the-Art Facilities
- •ISO Class cleanroom environments for sterile manufacturing
- •Validated manufacturing processes with continuous monitoring
- •Automated quality control systems
- •Environmental monitoring and control systems
Quality Assurance
- •100% product inspection protocols
- •Full traceability from raw materials to finished products
- •Regular third-party audits and inspections
- •Continuous improvement programs (CAPA)
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
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