ISO 13485: 2016 Requirement & Documentation Training and Workshops

9am~1pm

In-depth Understanding of the requirements for practical implementation in ISO 13485: 2016:

• Terms and Definitions
• Section 4 Quality management system ISO 13485:2016, including Medical Device File

Lunch Break

Workshop 1: Drafting sample process approach procedure (40 minutes).
In-depth Understanding of the requirements for practical implementation in ISO 13485: 2016 (continued)

• Section 4 Quality management system ISO 13485:2016, including Medical Device File (continued)
  
  • Section 5 Management responsibility

9am~1pm

In-depth Understanding of the requirements for practical implementation in ISO 13485: 2016 (continued):

• Section 6 Resource management
• Section 7 Product realization including Risk Assessment

Workshop 2: Establishing measurable quality objectives at relevant fucntion and level (35 minutes).

Lunch Break 

Workshop 3: Product Risk Assessment (35 minutes).
In-depth Understanding of the requirements for practical implementation in ISO 13485: 2016 (continued):

• Section 7 (continued) including
  • “Controlled room” and cleanliness of product and contamination control.
  • Process Validation/ Performance Qualification (PQ) and Installation Qualification (IQ) and operational Qualification (OQ).

9am~1pm

• Section 8 Measurement, analysis and improvement including
  • Post-market (post-production phase) Feedback System/ Medical Device Vigilance System.
    • Field Corrective Action.
    • Product Recall.
    • Issue of Advisory Notice.
    • Incident Reporting/ Notification of adverse events.
    • Complaint Handling.

Lunch Break 

• Section 8 Measurement, analysis and improvement including
  • Post-market (post-production phase) Feedback System/ Medical Device Vigilance System. (continued)