Clinical Trials with Medical Devices Boot Camp 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

Clinical Trials with Medical Devices Boot Camp 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

Clinical Trials with Medical Devices Boot Camp 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

Clinical Trials with Medical Devices Boot Camp 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

Clinical Trials with Medical Devices Boot Camp 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: “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

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