Tel +33(0)2 32 70 50 29
Fpster’s services & competences:
- Maintenance, Simplifying and development of Quality system.
- Products CE homologation Certifications Help for subcontracting (Sterilisation and conditioning)
(ISO 13485 ; ISO 11135 ; ISO 11137)
- Compliance FDA (21CFR part 820)
- Software Qualification (21 CFR PART 11)
- Process validation and performance optimization.
- Sterilisation facility qualification Help for subcontracting (γ, ß, EO, steam- QI, QO, QP)
- Validation process and development.
- Help for subcontracting Help for subcontracting (Sterilisation and conditioning)