Medical device

The medical device and pharmaceutical industries exert enormous global impact. Frost and Sullivan estimated the 2011 medical device industry revenue at $102.1 billion for the U. S. market . The European medical technology market has been estimated at €100 billion . According to a recent U.S. Patent and Trademark Office Patent Technology Monitoring Team Report, 16,538 patents were issued for medical devices or pharmaceuticals in 2012 . In the same year in Europe, more than 10,000 patent applications

description of the medical device approval process in the US and the UK, followed by an analysis on the benefits and deficiencies involved with each system. A final opinion on the superior system will then be given, with supporting statements. In the US, a branch of the Food and Drug Administration (FDA) called the Center for Devices and Radiological Health (CDRH) is responsible for regulating medical device approval, as well as monitoring the manufacturing, performance, and safety of devices. The CDRH regulates

disabilities) and recalls related to medical device are due to failures in the quality systems during the pre-market activities. The number of adverse event reports has increased dramatically; these post-market issues uncovered the failures in the quality systems such as design controls and production and process controls that could be a strong predictor for recall root cause. The number of complexity of medical devices has grown rapidly. In parallel, the medical device supply chain has become increasingly

The purpose of this memo is to describe the legal and regulatory environment in the medical device industry. The first section describes the industry while the second section describes the legal and regulatory environment in the medical device industry, with a focus on the agencies that regulate the industry and association that lobbies on the industry’s behalf. The third section highlights the issue whether government actors should regulate more or less within this industry. This issue is of paramount

“Macarena.” With each passing year, the sophistication of medical diagnostic devices increases with disruption to the traditional and centralized diagnostic delivery model. A review of five medical diagnostic devices available today, or coming soon to a healthcare facility near you, will be reviewed along with how it will disrupt the current model. Capsule Endoscopy According to Christensen, Grossman, and Hwang (2009), medical device and diagnostic equipment (MDDE) is progressively decentralized

Background The FDA introduced a new regulation that affects all FDA regulated medical device companies. This new regulation requires that the medical devices companies become compliant with the Unique Device Identifier (UDI) requirement within the next one to three years. Most of these medical device companies are not yet compliant and require a suitable solution to maintain their FDA certification. Description of the Product PRISYM ID has developed global label management solution (PRISYM

Medical Device Recall: This recall covered two areas: making claims in promotional materials that constitute a medical device but not filing the product as a medical device with the FDA and the water filtration system poses a risk of adverse health and/or death. This recall was designated as a Class I recall which is the FDA’s highest designation. The FDA first contacted the company over the labeling and that is when the company voluntarily recalled the filtration products after it reported to the

2.1. Percutaneous medical devices Percutaneous medical devices are increasingly used in several medical applications and are indispensable in the medical field [1]. Percutaneous devices are defined as foreign bodies crossing the epithelial barrier connecting external systems to the internal structure of the body(fig). Table 1 summarizes the list of percutaneous medical devices. These percutaneous medical devices breach the epithelial barrier in a temporarily or permanent manner; therefore, breaking

the public. The definition of safety or health can be unclear, especially for engineers when it comes to the medical device industry. In the medical device industry, the rapid increase of technology decreases the ability for regulations to keep up. When looking at job requirements for medical device engineers, one of the major requirements is to know the FDA guidelines on medical devices. The FDA guidelines are what engineers follow when it comes to designing. The FDA has its own goal to put products

As part of Class I sterile, the proposed medical design requires the certification and approval by a Notified Body (NB) for manufacturing and sterility standards [14]. At the same time the Council Directive 93/42/EEC recommends to conform to the EN ISO 13485 and EN ISO 14971 European standards, although it is not require [14][26][27]. Furthermore, for basic class I devices, only the declaration of conformity is required before receiving the CE marking, making market entrance more accessible for