Quality
Management System
More than certifications,
they are guarantees of safety,
traceability, and international
regulatory compliance.
Certifications
Biomecânica is certified under NBR ISO 13485:2016, an international Quality Management System standard specific to the medical device industry, maintaining this certification since 2007. It also holds the Good Manufacturing Practices (GMP) certification granted by ANVISA.
These certifications attest that our processes follow rigorous quality standards, ensuring full compliance with national and international regulatory requirements, while reinforcing our commitment to the safety, effectiveness, and reliability of our products.
Established Global Presence
We operate in 44 countries across Latin America, Asia, and Africa, with established partnerships in markets such as Thailand, Colombia, Kenya, Ecuador, the Dominican Republic, Argentina, Honduras, and Panama.
This international presence reflects our technical consistency and regulatory compliance, positioning Biomecânica as a global company ready to serve diverse markets with high-performance orthopedic solutions.