SFB Profile

Danielle Giroud RN, MBA


With over 20 years experience Ms. Giroud is widely regarded as one of the most recognized clinical research and regulatory experts within the medical device industry, having shared her extensive knowledge with multi-national corporations and startup companies from around the globe.

 

Ms. Giroud was the founder and CEO of D-TARGET, a leading clinical research organization specializing in medical device clinical trials throughout the European continent and is currently serving as senior faculty board member and founder of the World Medical Device Organization (WMDO), an independent professional organization dedicated exclusively to serving the professional development and educational needs of medical device professionals from around the world.





Courses: By this SFB
 
Conducting Medical Device Clinical Investigations in Singapore
ISO 14155: 2011 – A Summary Review
The European Medical Device New Regulation
GCP for Investigators: Clinical Investigation Conduct and Reporting
GCP for Investigators: Clinical Investigation Close out or Termination
ISO 14155:2011- Scope
ISO 14155:2011 - Ethical Considerations
ISO 14155:2011 - Clinical Investigation Planning
ISO 14155:2011 - Clinical Investigation Conduct
ISO 14155:2011 - Clinical Investigation Close Out
ISO 14155:2011 - Responsibilities of Sponsor
ISO 14155:2011 - Responsibilities of Principal Investigator
GCP for Investigators: How to Qualify for Medical Device Clinical Investigations
GCP for Investigators: Ethics and Legal Processes for Medical Device Clinical Investigations
GCP for Investigators: Initiation of a Medical Device Clinical Investigation
Directive 93/42/EEC and update 2007/47/EC: A review for clinical professionals (rev 1.2)
Adverse Event Processes
The Periodic Monitoring Visit
Device Accountability
Deviations and Non-Compliance Handling
Source Document Verification
The Case Report Form Process
Visit Report Writing
The Close Down Visit
Introduction to Medical Device and Clinical Investigation Planning
The Clinical Investigation Plan
The Informed Consent Process
Ethics Committee(EC) / Institutional Review Board Requirements
Selecting Investigation Sites
Initiation Visit
History of Good Clinical Practice (GCP)
Introduction to Good Clinical Practice
Conducting Medical Device Clinical Investigations in Germany
Data from prospective clinical investigation for CE-mark: review for regulatory professionals
Format and Structure of a Medical Device Clinical Investigation Plan/Protocol
Designing a Strategic Medical Device Clinical Investigation Plan/Protocol
Clinical Protocol Writing Process and Ensuring Compliance
Clinical Evaluation report of Existing data for CE-mark: review for regulatory professionals
CPM: Project Guidelines for Medical Device Clinical Trials
CPM: Managing Ongoing Medical Device Clinical Trials
CPM: Compliance Management during Medical Device Clinical Trials
CPM: Effective Communication Methods during Medical Device Clinical Trials
CPM: Close Out and Clinical Report of a Medical Device Clinical Trial
CPM: The Clinical Trial master plan for Medical Devices
CPM: Medical Device Clinical Trials - Budget and Timelines Planning
CPM: Medical Device Clinical Trial Team Resources
CPM: Tracking and Reporting Rules for Medical Device Clinical Trials
CPM: Objectives and Setup of a Medical Device Clinical Trial
ISO 14155 Version 2003 vs. 2011: Gap Analysis
The Lifecycle of Medical Devices from Idea to Market
Clinical Evaluation of Medical Devices: an Introduction
Post Market Surveillance: an Introduction
GCP for Investigators: Introduction to Medical Devices
CMDA Clinical Evaluation - Test Exam online
Managing Data Release Consent During Post Market Studies
European Safety Reporting Requirements during Pre-Market clinical Investigations


Articles: By this author








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