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

of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices...

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...

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...

Durable medical equipment (DME) is a category of medical devices designed to assist individuals with disabilities, injuries, or chronic health conditions...

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...

Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This...

States), is a medical device designed and manufactured for the sole use of a particular patient. Examples of custom-made medical devices include auricular...

Defense Blood Standard System (DBSS) is a FDA-regulated, Class II Medical Device designed to handle blood collection, processing and tracking procedures...

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...

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

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

that medical devices fulfil their intended purpose. Validation or verification is generally needed when a health facility acquires a new device to perform...

and high-quality medical devices and safe radiation-emitting products. Examples of products that CDRH regulates include medical devices ranging from tongue...

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...

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

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)...

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

Retriever is a medical device designed to treat Ischemic Strokes. The name is an acronym for Mechanical Embolus Removal in Cerebral Ischemia. Designed by University...

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

Data. O'Reilly Media, Inc. ISBN 978-1492072744. Fries, Richard C. (2019-08-15). Handbook of Medical Device Design. CRC Press. ISBN 978-1-000-69695-0....

fields of robotics, advanced materials, sensors, custom machinery, medical device design, biopharmaceuticals, C4ISR and transportation. It has been awarded...

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

muscular dystrophy Craniomandibular dysfunction Custom-made device, a medical device designed and manufactured for the specific use of a particular patient...

The Organ Care System (OCS) is a medical device designed by Transmedics to allow donor organs to be maintained for longer periods of time prior to transplant...

Balt is a medical equipment manufacturer specializing in medical devices designed to treat stroke and other neurovascular diseases. Balt was established...

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