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Business Conference

HOW WE HELP

REGULATORY SUPPORT

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

QUALITY MANAGEMENT SYSTEM

QMS Design
QMS Implementation
QMS Monitoring and Data Analysis
QMS Training

ISO CERTIFIED LEAD AUDITORS

Internal Audit Support
Regulatory Audit Support
Supplier Audit Support

RISK MANAGEMENT

ISO 14971 Gap Analysis & Remediation
FMEA Development
GSPR Compilation

PROBLEM-SOLVING & PROCESS IMPROVEMENT

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

CONTROLLED ENVIRONMENT

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

BIOCOMPATIBILITY SUPPORT

Biological Safety Risk Assessment
BSE Study Design & Support
BSE Report Drafting

STERILISATION SUPPORT

Sterilisation Process Design and Support
Validation Protocol Design
Validation Report Drafting

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

Manufacturer PRRC
Authorised Representative PRRC
PRRC Agreements/ Mandates

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