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... |
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... |
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... |
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 ... |
2 years ago |