.01

Understand regulatory requirements for EU-MDR/IVDR, ISO 14971 and ISO 13485

.02

Understand key objectives, deliverables and linkages to other parts of your QMS

.03

Learn about different data sources and data analysis methods

.04

Learn about the SNIP method for timely and effective handling of safety signals

.05

Learn about industry best practices in effective operation and governance

This workshop is perfect for:

• Senior Quality and Compliance Leaders

• Risk Managers

• Medical Safety Officers

• Quality Managers and Quality Engineers

• Regulatory Compliance & Regulatory Affairs Managers

• Product Developers

• Product Quality Engineers

You will receive:

1. Certificate of completion

2. Workshop slides

3. Breakout session slides and worksheets