Our team of professionals rigorously monitors the conformity of the parts you entrust us to manufacture.

Coulot Decolletage is certified ISO 13485 21CFR

LNE-GMED, ANVISA and FDA (n° 3006217744)

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