2003 - ISO 9001 and ISO 13485 by AB Certification
2005 - FDA Registration
2009 - FDA Registration
2013 - ISO 13485 by LNE-GMED
2013 - ANVISA and FDA Inspection
2018 - ISO 13485 (2016) by LNE-GMED
2020 - Audit ISO 13485 by LNE-GMED
our quality culture
In compliance with ISO regulatory requirements and the control of internal quality processes, combined with rigorous controls carried out by our experts, guarantee the conformity of each component, in accordance with our customers’ requirements.
Each manufacturing step is carried out under the strict control of the respect of QHSE constraints.
our team
1 Quality Manager
1 System Quality Manager
1 Production Quality Manager
