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ISO 13485 Renewal

News

We are pleased to announce the renewal of our Recommendation for ISO 13485:2016 Certification. This achievement represents a significant milestone for our reputation and reinforces our ongoing commitment to excellence.

It is a widely recognized international standard that outlines quality management system requirements for the medical device sector. It covers all stages of the product lifecycle: from design and development to production, installation, and support… ensuring that medical devices are safe, effective, and compliant with regulatory and stakeholder requirements.

We are extremely proud of the dedication and hard work of our entire team. This recognition is a testament to our collective effort to overcome challenges and continuously strive for improvement. Congratulations to everyone on this important achievement!

July 29, 2025
Tags: Alexandre Fuzinelli, Antônio Lima, Brazil, Certification, COO, Daniela de Moraes, Guilherme Tosetto, HR Analyst, HR Manager, Industrial Manager, Innovation Manager, ISO 13485, José Renato Batista, Katia Renubia, Maria Alice Lima, Monica Biajo, Monica Vilah, Priscila Domingues, Product Engineer, Quality Manager, Ryan Passos, São Paulo, Sula Lacerda
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