Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance
Category: Medical Devices , Clinical Research , Marketing and Promotion , QMS, ISO 13485, CAPA , GCP & Other Best Practices , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)
Category: Medical Devices , Clinical Research , All FDA Regulated Industry , Drug and Device Approvals , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Creating a Global Regulatory Plan
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Drug Marketing Compliance , Marketing and Promotion , Documentation and IT , Laboratory , Clinical Trial Regulations , Biotech Regulations , All FDA Regulated Functions , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

How to file a 510(k) when your device is (or contains) software
Category: Medical Devices , Clinical Research , Marketing and Promotion , Clinical Trial Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Is your Essential Requirements Checklist (ERC) up to snuff?
Category: Medical Devices , Supply Chain and Manufacturing , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Category: Medical Devices , Clinical Research , All FDA Regulated Industry , Drug and Device Approvals , Marketing and Promotion , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Understanding the Mobile Medical Applications Guidance
Category: Medical Devices , Marketing and Promotion , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Is Device Registration and Listing Stressing You Out?
Category: Medical Devices , Marketing and Promotion , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?
Category: Medical Devices , Testing and Validation , Audits & Inspections , QMS, ISO 13485, CAPA , R & D , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices
Category: Medical Devices , Testing and Validation , Audits & Inspections , QMS, ISO 13485, CAPA , R & D , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Research & Development , Device R & D , Regulations & Guidances , Regulatory Affairs , Documentation and Data Management , QA/QC