QUALITY PROCEDURES & CERTIFICATIONS
Cefimeca is committed to a stringent quality system to meet the requirements of our customers and constantly evolving regulations in the medical sector.
Traceability, which lies at the very heart of our quality system, is ascertained by the creation of a technical file specific to each medical device and the archiving of batch files without any time limit.
Reproducibility and conformity of parts is ascertained via the use of equipment protocols, approval of processes and an inspection team that is fully integrated to the quality department.
Our widely recognised expertise when it comes to precision engineering for the medical sector represents a major asset for all our customers.
The following certifications and inspections bear witness to our efficiency and constant improvement of our Quality system:
- ISO 13485 certification since 2008 granted by LNE/GMED
- FDA 21 CFR inspection
- ANVISA RDC 16/2013 inspection
1 quality manager
1 validation engineer
3 quality assistants
1 quality metrology assistant