bpadgett@msm.edu

Forum Replies Created

Regulatory Basics

The Food and Drug Administrations (FDA) and Center for Devices and Radiological Health (CDRH) governs companies who manufacture, relabel, repackage, or import medical devices sold in the United States...

In forum Regulatory Basics for Medical Devices

2 years ago
Quality To The Rescue

Quality assurance and control is a vital part of quality management. Quality ensures that a product successfully makes it through the manufacturing process. Verifications throughout processing helps p...

In forum Quality Control and Quality Assurance

2 years ago
RE: Design Verification & Validation vs Clinical & Pre-Clinical Trials

The Design and Development phase typically follows a Project Planning phase. According to the FDA, design verification is confirmation by examination and provision of evidence that requirements are f...

In forum Introduction to Design Controls

2 years ago
RE: Animal Diversity in Pre-clinical Research

NAMSA is a medical contract research organization that offers preclinical development support. They use cutting-edge technology with all preclinical research services. NAMSA’s field of experts covers ...

In forum Pre-clinical Device Development

2 years ago
RE: Animal Diversity in Pre-clinical Research

NAMSA is a medical contract research organization that offers preclinical development support. They use cutting-edge technology with all preclinical research services. NAMSA’s field of experts covers ...

In forum Pre-clinical Device Development

2 years ago
Pre-Clinical Device Development

Medical device development is a arduous process with rigid requirements that must be met by FDA's approval and other compliances. The lifecycle require a system of phases to ensure safe and effective ...

In forum Pre-clinical Device Development

2 years ago
The Five Phases of Medical Device Development

Medical device development is a arduous process with rigid requirements that must be met by FDA's approval and other compliances. The lifecycle require a system of phases to ensure safe and effective ...

In forum Pre-clinical Device Development

2 years ago
Project Management Drives Changes

Project management requires specific knowledge, skills, and tools to deliver something of value to people. Project managers are people who ensure that a project's team meets their goals. Project profe...

In forum Intro to Project Management

2 years ago
RE: Leah Banks - Merging Lanes for Medical Devices and Communication

Your thoughts and awareness on bridging the gaps through journalism on health literacy and health advocacy on medical devices is a great one. Primarily, there should be more knowledge and understand o...

In forum Introduction to Medical Device Development

2 years ago
The Medical Device School - From Concept to Marketing

The FDA works with some medical device schools that provide comprehensive programs designed to map the processes from device concepts to marketing. They provide the foundational steps from regulatory ...

In forum Introduction to Medical Device Development

2 years ago
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