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Implant (medicine)

implantimplantsmedical implant
One example of high-risk devices are those with Embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses.
An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure.

Global Harmonization Task Force

global harmonizationInternational Medical Device Regulators Forum
Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of the definition of a medical device, thus the appropriate definition of a medical device depends on the region.
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world.

Medical Devices Directive

Medical Device Directive(93/42/EEC)93/42/EEC
Medical device regulation in Europe as we know it today came into effect in the 1993 by what is collectively known as the Medical Device Directive (MDD).
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union.

Biomedical engineering

biomedical engineermedical engineeringbiomedical
The design of medical devices constitutes a major segment of the field of biomedical engineering.
Prominent biomedical engineering applications include the development of biocompatible prostheses, various diagnostic and therapeutic medical devices ranging from clinical equipment to micro-implants, common imaging equipment such as MRIs and EKG/ECGs, regenerative tissue growth, pharmaceutical drugs and therapeutic biologicals.

Medicines and Healthcare products Regulatory Agency

MHRAMedicines and Healthcare Products Regulatory Agency (MHRA)Medicines Control Agency
In the UK, for example, the Medicines and Healthcare products Regulatory Agency (MHRA) acts as a CA.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Embedded system

embedded systemsembeddedembedded device
One example of high-risk devices are those with Embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses.
Medical equipment uses embedded systems for vital signs monitoring, electronic stethoscopes for amplifying sounds, and various medical imaging (PET, SPECT, CT, and MRI) for non-invasive internal inspections.

Federal Food, Drug, and Cosmetic Act

Food, Drug, and Cosmetic ActFood, Drug and Cosmetic ActFederal Food, Drug and Cosmetic Act
On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.

Notified Body

Notified Bodies
The conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the Notified Body, before it can be placed on the market.
For example, a notified body may designate that a medical device conforms to the Medical Devices Regulation (MDR (EU) 2017/745) which defines the applicable legislation, including the general safety and performance requirements, for medical devices.

Postmarketing surveillance

post-marketing surveillancepostmarket surveillancepostmarketing reports
Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance.
Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

EU medical device regulation

Medical Device RegulationMedical Devices Regulation
On May 26, 2017 the Medical Device Regulation (MDR) replaced the MDD.
The European Union Medical Device Regulation (Council Regulation 2017/745 of 5 April 2017 concerning medical devices, OJ No L 117/1 of 2017-05-05) repeals the existing directives on medical devices: Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC].

ISO 13485

ISO 13485:2003ISO13485ISO
The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices. On 28 December 2016 the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet-connected devices.
The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

IEC 62304

IEC 62304:2006IEC 62304:2006 "Medical device software – Software life cycle processesIEC 62304:2006 "medical device software –software life cycle processes
Further standards are IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered), EN 45502-1 which is for Active implantable medical devices, and IEC 62304 for medical software.
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices.

Good manufacturing practice

Good Manufacturing PracticesGMPcGMP
The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

ISO 14971

The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971.
ISO 14971 is an ISO standard for the application of risk management to medical devices.

Design controls

design control
Subpart B includes quality system requirements, an important component of which are design controls (21 CFR 820.30).
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices).

IEC 60601

IEC 60601-1IEC 60601-1-2IEC60601
Further standards are IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered), EN 45502-1 which is for Active implantable medical devices, and IEC 62304 for medical software.
For example, IEC 60601-1-9 for Environmentally Conscious Design of Medical Electrical Equipment published July 2007 is a collateral standard to IEC 60601-1 and has been developed drawing on extensive practical experience at Philips Medical Systems and Siemens Medical Solutions.

Medical device design

device manufacturersmedical device manufacturerMedical devices
On 28 December 2016 the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet-connected devices.
Medical device design, as the name suggests, refers to the design of medical devices.

Package testing

packagePerformance testing
Package testing documents and ensures that packages meet regulations and end-use requirements.
pharmaceuticals, medical devices, dangerous goods, etc.

Global Medical Device Nomenclature

GMDN
The identification of medical devices has been recently improved by the introduction of Unique Device Identification (UDI) and standardised naming using the Global Medical Device Nomenclature (GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF).
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products.

Biomedical equipment technician

biomedical equipment technicians (BMETs)BMETBio-Medical Equipment Technology
A biomedical equipment technician (BMET) is a vital component of the healthcare delivery system.
A biomedical engineering/equipment technician/technologist (BMET) or biomedical engineering/equipment specialist (BES or BMES) is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional.

Substantial equivalence

substantially equivalentSubstantial-Equivalency
In 2018, an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k) substantial equivalence process; the investigation prompted similar calls in the UK and Europe Union.
Adopting the term, substantial equivalence was formulated as a food safety policy by the OECD, first described in their 1993 report, "Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles. The term was borrowed from the FDA's 1976 substantial equivalence definition for new medical devices—under Premarket Notification 510(k), a new Class II device that is essentially similar to an existing device can be cleared for release without further testing. The underlying approach of comparing a new product or technique to an existing one has long been used in various fields of science and technology.

Food and Drugs Act

Food and Drug ActFood and Drug ActsFood and Drug Directorate
The term medical device, as defined in the Food and Drugs Act, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug."

Computer security

cybersecuritycyber securitysecurity
In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices, in response to the growing risks of limited cybersecurity.
Medical devices have either been successfully attacked or had potentially deadly vulnerabilities demonstrated, including both in-hospital diagnostic equipment and implanted devices including pacemakers and insulin pumps.

Anaesthetic machine

anesthetic machineanesthesia machineanesthesia machines
An anaesthetic machine (British English) or anesthesia machine (American English; [[American and British English spelling differences#Miscellaneous spelling differences|see spelling differences]]) is a medical device used to generate and mix a fresh gas flow of medical gases and inhalational anaesthetic agents for the purpose of inducing and maintaining anaesthesia.