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MDR 2017/ 745 Gap Analysis & RemediationTechnical Documentation Review and RemediationUS FDA Facility Registration, 510k and PMA Support
QMS DesignQMS ImplementationQMS Monitoring and Data AnalysisQMS Training
Internal Audit SupportRegulatory Audit SupportSupplier Audit Support
ISO 14971 Gap Analysis & RemediationFMEA DevelopmentGSPR Compilation
Problem-Solving Training & SupportProcess Improvement Training & SupportData Analysis
Controlled Environment GMP TrainingISO 14644 Training & SupportISO 14698 Training & SupportRoutine Monitoring Support
Biological Safety Risk AssessmentBSE Study Design & SupportBSE Report Drafting
Sterilisation Process Design and SupportValidation Protocol DesignValidation Report Drafting
Manufacturer PRRCAuthorised Representative PRRCPRRC Agreements/ Mandates