Tailor Surgery Achieves ISO 13485 Certification: Quality Assurance in Personalized Medical Devices
Tailor Surgery is proud to announce the achievement of ISO 13485 certification, granted by the accredited body NQA. This internationally recognized standard confirms our compliance with the most stringent quality and safety requirements in the manufacturing of medical devices. Our portfolio includes patient-specific solutions —such as 3D anatomical models, surgical guides, and customized implants— designed to enhance surgical planning and improve clinical outcomes in orthopedic and trauma surgery.
Innovation and Regulatory Compliance in Medical Devices
The medical device industry is subject to rigorous international regulations. Achieving ISO 13485 certification validates that our personalized surgery processes fully comply with these standards, ensuring patient safety, traceability, and reliability in every medical product we deliver. This milestone reinforces our commitment to transparency, trust, and excellence.
3D Technology Applied to Orthopedic and Trauma Surgery
At Tailor Surgery, we support orthopedic and trauma surgeons in high-complexity personalized surgical planning through 3D printing technology combined with deep clinical expertise. Our mission is clear: to increase precision in the operating room, reduce risks, minimize complications, and accelerate patient recovery times.
Values Driving Our Mission — Now Certified
The ISO 13485 certification consolidates the principles that guide our growth in healthcare:
- Innovation and surgical quality: transforming orthopedics with advanced 3D solutions that make a difference.
- Safety and clinical reliability: designing and manufacturing patient-specific medical devices under the highest international standards.
- Medical collaboration: working closely with surgeons and hospitals to achieve surgical excellence.
- Global regulatory compliance: strengthening our leadership and opening new international markets.
- Excellence and trust: certified processes that guarantee sustainability, quality, and safety for both surgeons and patients.
With this achievement, we reaffirm our mission: to continue innovating and improving lives through personalized surgery.
A Step Forward in Personalized Medicine, Thanks to Our Team
This milestone would not have been possible without the dedication of our multidisciplinary team, as well as our technology partners and healthcare suppliers. ISO 13485 certification drives us to keep developing customized medical solutions for orthopedic and trauma surgery, always prioritizing patient safety.
👉 Learn more about our commitment to surgical innovation and access the official certificate at: www.tailorsurgery.com