Certification
Certifications & Compliance
Committed to Quality and Global Standards
At SAK BRACE, quality, safety, and regulatory compliance are the foundation of everythingwe do.
Our orthopedic braces are manufactured under strict quality management systems to
ensure consistent performance, safety, and reliability.
We comply with internationally recognized medical device standards and continuouslyimprove our processes to meet the regulatory requirements of global markets.
Through these certifications, we demonstrate our commitment to providing trustedorthopedic support products to distributors, medical professionals, and healthcareinstitutions worldwide.
Our Certifications
ISO 13485 Certified Orthopedic Brace Manufacturer with CE Marking and EU MDR Compliance
ISO 13485:2016 Certified Orthopedic Brace Manufacturer | Medical Device Quality Management System
CE MDR Certified Orthopedic Braces Supplier | EU Medical Device Compliance
CE MDR Certified Orthopedic Braces Supplier | EU Medical Device Compliance
Class I Medical Device Manufacturing Filing Certificate China | Orthopedic Brace Manufacturer Approval
Class I Medical Device Filing – Orthopedic External Fixation Splint Manufacturer China
Adjustable Orthopedic Brace Class I Medical Device Filing Certificate China
Medical Support Strap Class I Medical Device Filing China Manufacturer
Orthopedic External Fixation Brace Class I Medical Device Filing China Supplier
Request Certification Documents
If you require certification documents for product registration, regulatory approval, or distributor cooperation, our team will be happy to assist you.