Referenzen
Global medical technology manufacturer – FDA-compliant risk management
Kategorie
ISO 13485
Branche
Medical technology
Unternehmen
International holding company with approximately 31,000 employees
Ansprechpartner
Günter Nuss
Ausgangssituation
Several global production sites; a process landscape that has evolved over time with inconsistent RM; validation documentation (IQ, Installation, OQ, Operational, PQ, Performance) not consistently harmonised; FDA audits are becoming increasingly critical, highlighting non-conformities
Herausforderung
Complex regulatory requirements (FDA, ISO 14971, MDR). A lack of consistent PFMEA structures across critical – and, in particular, innovative – manufacturing processes such as vacuum brazing, assembly and testing. The client required a partner with an in-depth understanding of medical technology processes, regulatory compliance and the practical implementation of PFMEA.
Lösungsansatz
Documentation and analysis of current processes
Establishment of an FDA-compliant PFMEA framework
Derivation of process test strategies
Preparation and harmonisation of validation documents (IQ/OQ/PQ)
Workshops with RD and Q; support until the organisation is ready for an FDA audit
Ergebnis
Robust, audit-proof PFMEA for critical and innovative processes; a targeted, clearly defined validation workflow; a reduction in regulatory FDA findings; improved and systematic root cause analysis, reproducibility and process stability
Günter Nuss
Managing Director
