Qualità e conformità
(solo in tedesco, francese e inglese)
In the field of medical technology products, quality regulations are particularly strict. This applies to all processes, including the means of production used and their environment. Cendres+Métaux has in-depth knowledge of the applicable regulations.
Our processing systems and equipment have all the necessary qualifications, including cleaning technology for cleanliness from level 1 (free from operating residues) up to level 4 (with microbiological requirements) and for clean rooms (ISO class 7). We are regularly certified (MDD 93/42/EEC, ISO 13485 / 14001 / 9001) as well as registered as a subcontractor with the FDA and jPAL. Furthermore, additional customer-specific procedures can also be agreed and integrated.
- Certified according to MDD 93/42/EEC, ISO 13485 / 14001 / 9001
- FDA-registered supplier according to 21CFR820
- Registered certification according to jPAL
- Accredited as a testing laboratory according to ISO/IEC 17025
- Qualification & auditing of suppliers
- Traceability across products, materials used and processes
- Testing and process integration:
- Process development & validation (IQ, OQ, PQ)
- First Article Inspection (FAI)
- Statistical Process Control (SPC)
- Management of sterilisation validation