DE
Wir entwickeln projektbegleitend oder Stand-alone, bewerten und implementieren die erforderlichen Dokumente entsprechend ihres Qualitäts-Standards für Luftfahrt, Automobil und Medizintechnik.
EN
We develop during the project phase or stand-alone, evaluate and implement the required documents according to Your quality standards for aerospace, automotive and medical device industries.
Aufgaben/Assignments
QMS - review, design and review for different standards: - EN ISO 13485, TS 16949, EN ISO 9001.
Design, review and implementation of Standard Operational Procedures (SOP)
Risk Management file according to EN ISO 14971 für CE und FDA clearance:
Development of Risk Management File right from the beginning
Risk Management Plan, Essential Requirements, Intended Use, Risk Acceptance Matrix, Hazard Analysis, FMEA, Risk Control, Usability
From specifications to qualification
Specification, Installation Qualification, Performance Qualification, Operational qualification