Medical Devices and Pharma
Medical device and pharmaceutical regulatory consulting and health safety informationWelcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
- Regulatory services for compliance, market access, and crisis management
- Information about innovation, including new products cleared for use in the U.S. market.
- News stories with topics ranging from product issues to market trends.
Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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The Latest Posts
FDA Enforcement
The Food and Drug Administration (FDA) in the United States employs various enforcement mechanisms to ensure compliance with regulatory requirements and to protect public health. These mechanisms are essential for maintaining the safety, efficacy, and quality of food,...
Overview of ISO 13485
ISO 13485, Medical devices quality management systems ISO 13485, Medical devices quality management systems, is an international standard that specifies requirements for a quality management system (QMS) for medical device manufacturers. It also outlines requirements...
FDA Quality System Regulation – 21 CFR 820
QMSR CentralFDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known as the Quality System Regulation (QSR), outlines the requirements for the establishment and maintenance of a quality management system for medical device manufacturers in the United States....
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by delivering electrical impulses to the spinal cord. The system typically consists of several components: Implantable Pulse Generator (IPG) This is the...
Prospera Spinal Cord Stimulation System for Intractable Back Pain
Prospera Spinal Cord Stimulation System FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs. This implanted system comprises a...