ISO 13485 2Day

Delivering in-house training in ISO 13485, Medical Devices- Quality Management Systems-Requirements for Regulatory Purposes

Call Rachel McLean +44(0)1292 671555

ISO 13485

Designed and developed for delegates who have a complete understanding of Quality Systems and wish to design, document, develop, improve and maintain their Quality Management System to ISO13485 Requirements

Day 1 Course Contents

Review of the Standard & Design Requirements

Process Model & limitations
Key Regulatory Requirements to be addressed & included in the Management System
- EC Medical Device Directives
- FDA CFR 820
- Health Canada CMDCAS
Quality System Requirements & Processes
Management Processes
Resourcing Processes
Product Processes
Measurement, Analysis & Improvement Processes
Design & Linkages to CFR 820 Design Control
- Planning
- Inputs & Risk Management
- Outputs
- Review
- Verification
- Validation

Call Rachel McLean on +44(0)1292 671555 or email rachel@gpb.ltd.uk to discuss your needs.

Day 2 Course Contents

Process Validation & CAPA

Process Validation
- What Process Require to be validated?
- Models / Tools
- Procedures
- Records
- Process Changes
CAPA
- Process Monitoring
- Product Monitoring
- Data Collation & Analysis
- Corrective Action
- Preventive Action
- Procedures
- Records