Services list

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)