Ensure Compliance to FDA's Design Control Requirements by using Requirements Management Techniques
Category: All FDA Regulated Industry , Quality Management , Quality and Safety , Life Sciences

Key Considerations in Verification & Validation of Medical Devices
Category: Medical Devices , Testing and Validation , Life Sciences

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971
Category: Medical Devices , Risk Management , Risk Management & Controls , All FDA Regulated Functions , Life Sciences

Creating a Good Design History File (DHF) for Audit Success
Category: Medical Devices , Audits & Inspections , R & D , Audit & Inspection-Role , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Research & Development , Device R & D , Life Sciences , Regulatory Affairs , Documentation and Data Management

Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Category: Medical Devices , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Life sciences QA/QC , QA/QC

Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)
Category: Medical Devices , Life Sciences , Documentation and Data Management

Learning Design Controls through review of FDA 483 Observations
Category: Medical Devices , All FDA Regulated Industry , GXP Medical Devices , FDA Validation , Testing and Validation , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , R & D , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Problem Solving using DMAIC
Category: Medical Devices , All FDA Regulated Industry , FDA Audit and Inspection , GXP Medical Devices , FDA Validation , Testing and Validation , Documentation and IT , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Medical Device Registration and Regulatory Submissions Know How for RA Professionals - Training Bundle
Category: Medical Devices