Regulatory Science Symposium: Clinical Trials with Medical Devices Session 2: History, Terms/Definitions and Regulatory Requirements (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Tagged: regulatory science , clinical trials , medical devices

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 5: Medical Device Feasibility Clinical Trials – SetPoint Medical Case Study (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Tagged: regulatory science , clinical trials , medical devices

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 6: Advanced International Trials with Medical Devices (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Tagged: regulatory science , clinical trials , medical devices

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 7: Auditing of Medical Device Trials (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Tagged: regulatory science , clinical trials , medical devices

Regulatory Science Symposium: Clinical Trials with Medical Devices Session 8: Gaps and Opportunities in Pediatric Device Trials (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Tagged: regulatory science , clinical trials , medical devices , pediatrics

Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 1: Introduction (2021)

Tagged: regulatory science , clinical trials , medical devices , quality science

Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 2: Clinical Investigation: Principles from Harmonized Documents (2021)

Tagged: medical devices , guidances , international medical device regulators forum (imdrf) , global harmonization task force (ghtf) , harmonization , standards

Regulatory Science Virtual Symposium: “Clinical Research Career Pathways” Session 2: From Academics to Industry – A Physician Researcher Perspective (2021)

Tagged: regulatory science , study design , clinical trials , medical devices , quality science , global research

Regulatory Science Virtual Symposium: “Emerging Technologies in the Medical Device Industry” Session 6: Cybersecurity (2022)

Tagged: medical devices

Regulatory Science Virtual Symposium: “Make Informed Decisions: Key Statistical Principles to Clinical Trial Design” Session 3: Designing Medical Devices (2022)

Tagged: medical devices , clinical trial design , adaptive design

Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 3: Good Clinical Practices and ISO 14155 (2021)

Tagged: medical devices , quality risk management , good clinical practices (gcp) , quality management , international organization for standard (iso)

Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 4: From Clinical Data to Clinical Evidence (2021)

Tagged: study design , clinical trials , medical devices , clinical evidence , validation , quality

Regulatory Science Virtual Symposium: “Principles of Global Clinical Research for Medical Devices” Session 5: Developing Clinical Evaluations (2021)

Tagged: medical devices , global harmonization task force (ghtf) , clinical evaluation , clinical evaluation report (cer), , essential principles (ep) , appraisal process

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 3: Gender, Race, and Ethnicity in Clinical Trials (2023)

Tagged: regulatory science , medical devices , diversity , inclusion , regulatory and quality sciences , clinical trial design

Regulatory Science Virtual Symposium: “Study Design for Clinical Trials: Types and Trends” Session 5: Medical Device Trials (2023)

Tagged: regulatory science , clinical trials , medical devices , regulatory and quality sciences , translational science

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