HOW WE HELP

PFAS MANAGEMENT

PFAS Risk/ Exposure Assessment

PFAS Testing

PFAS Remediation

PFAS Exemptions

PFAS Reporting

Internal Audit Support
Regulatory Audit Support
Supplier Audit Support

QMS Development & Training

MDR 2017/ 745 Gap Analysis & Remediation
Technical Documentation Review and Remediation
US FDA Facility Registration, 510k and PMA Support

EU MDR Authorised Representative

EU AI Authorised Representative

GDPR Representative

Manufacturer PRRC
Authorised Representative PRRC
PRRC Agreements/ Mandates

ISO 14971 Gap Analysis & Remediation
FMEA Development
GSPR Compilation

Problem-Solving Training & Support
Process Improvement Training & Support
Data Analysis

Controlled Environment GMP Training
ISO 14644 Training & Support
ISO 14698 Training & Support
Routine Monitoring Support