Medical device design information

industry, the design of medical devices presents significant challenges from both engineering and legal perspectives. The United States medical device industry...

medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical...

A medical device hijack (also called medjack) is a type of cyber attack. The weakness they target are the medical devices of a hospital. This was covered...

A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF...

design plan and 21 CFR 820.30. The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device...

that acts as an accessory to a medical device. Software used in the design, production, and testing of a medical device (or) Software that provides quality...

(or auto-injector) is a medical device designed to deliver a dose of a particular drug. The injectors were initially designed to overcome the hesitation...

Team Consulting is a medical device design and development consultancy. The company works with pharmaceutical companies and Medtech businesses globally...

A mobile device or handheld computer is a computer small enough to hold and operate in the hand. Mobile devices are typically battery-powered and possess...

a home medical device designed to assist in the treatment of benign paroxysmal positional vertigo (BPPV) and its associated vertigo. The device is a head-worn...

recall. Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish...

Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare...

Globus Medical, Inc. is a publicly traded medical device company headquartered in Audubon, Pennsylvania, United States. Globus is focused on the design, development...

autoinjectors in use with the US Armed Forces. An autoinjector is a medical device designed to deliver a single dose of a particular (typically life-saving)...

contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier...

hazardous drugs. ICU Medical product line includes intravenous therapy (IV) products, pumps, needle-free vascular access devices, custom infusion sets...

is a wearable medical device designed to improve the functional vision of those living with low vision or legal blindness. The device was developed by...

entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite...

balloon-stent is often part of the assembled device, other features may also be part of the medical device design depending on the nature of the procedure...

of medical device design and development, production processes and evaluation of field experience, and is applicable to all types of medical devices. The...

The Turkish Medicines and Medical Devices Agency (TMMDA; Turkish: Türkiye İlaç ve Tıbbi Cihaz Kurumu) is a regulatory agency of the Government of Turkey...

of the cane. This dramatically increases traction on ice. The device is usually designed so it can easily rotate to the side to prevent damage to indoor...

intrauterine device (IUD), also known as intrauterine contraceptive device (IUCD or ICD) or coil, is a small, often T-shaped birth control device that is inserted...

Six Sigma for Medical Device Design, CRC Press, pp. 35–63, 2004-11-15, retrieved 2023-10-15 Brue, Greg; Launsby, Robert G. (2003). Design for Six Sigma...