Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance
Category: Medical Devices , GXP Medical Devices , Testing and Validation , QMS, ISO 13485, CAPA , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Risk Based Design Control
Category: Medical Devices , Risk Management , All FDA Regulated Industry , GXP Medical Devices , Testing and Validation , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Best Practices & GXPs , Life Sciences , QA/QC

How to prepare a 510(k) FDA Submission
Category: Medical Devices , Clinical Research , All FDA Regulated Industry , Drug and Device Approvals , Marketing and Promotion , Documentation and IT , Supply Chain and Manufacturing , Clinical Trial Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance
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 , R & D , Audit & Inspection-Role , Quality Audit , All FDA Reg. based Audit , Medical Device Inspection , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Regulatory Affairs , Common FDA Regulations , QA/QC

MDR Program conforming to New FDA Guidance
Category: Medical Devices , Audit & Inspection , Healthcare Compliance (Hospitals) , Marketing and Promotion , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , HEALTHCARE , Hospital Management , Audit & Inspection-Role , Medical Device Inspection , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Medical Device Cybersecurity Following New FDA Guidance
Category: Medical Devices , GXP Medical Devices , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , IT Regulations , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Regulations & Guidances , Regulatory Affairs , QA/QC

Qualification of Contract Manufacturer Organizations Based on Practical Experience
Category: Medical Devices , 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 , QA/QC

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
Category: Medical Devices , Risk Management , All FDA Regulated Industry , GXP Medical Devices , Marketing and Promotion , Testing and Validation , Documentation and IT , Quality and Safety , Supply Chain and Manufacturing , R & D , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC