Sources
 | This article about the economy is a stub. You can help Wikipedia by expanding it. |
The European Medical Devices Industry Group (EMIG) is a non-profit trade association, and represents the medical devices industry in Europe as defined by the European Union Medical Devices Directives (93/42/EEC). Karen Howes is the current chair person of EMIG.
| | This article about the economy is a stub. You can help Wikipedia by expanding it. |
Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications. BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy. Also included under the scope of a biomedical engineer is the management of current medical equipment in hospitals while adhering to relevant industry standards. This involves procurement, routine testing, preventive maintenance, and making equipment recommendations, a role also known as a Biomedical Equipment Technician (BMET) or as a clinical engineer.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
The Restriction of Hazardous Substances Directive 2002/95/EC, short for Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment, was adopted in February 2003 by the European Union.
The presence of the logo on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA); goods sold elsewhere may also carry the mark.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.
The electronics industry is the economic sector that produces electronic devices. It emerged in the 20th century and is today one of the largest global industries. Contemporary society uses a vast array of electronic devices that are built in factories operated by the industry, which are almost always partially automated.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.
COCIR is the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry. It is a non-profit trade association, which was founded in 1959, and represents the medical technology industry in Europe. Since 2006 COCIR headquarters are located in Brussels. In 2007, Heinrich von Wulfen became its chairman and succeeded Frank Anton. COCIR is a member of the European Medical Devices Industry Group (EMIG).
Eucomed was the organisation that represented the interests of the medical device industry in Europe. It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. Eucomed represents a total of 11,000 legal entities in Europe. It is now part of MedTech Europe.
A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. The CE certificate and declaration of conformity can only be issued by a company located in the European Union.
The following outline is provided as an overview of and topical guide to clinical research:
A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
ISO 14971Medical devices — Application of risk management to medical devices is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51, and ISO/IEC Guide 63. The third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Cyborg data mining is the practice of collecting data produced by an implantable device that monitors bodily processes for commercial interests. As an android is a human-like robot, a cyborg, on the other hand, is an organism whose physiological functioning is aided by or dependent upon a mechanical/electronic device that relies on some sort of feedback.
Electronics right to repair is proposed legislation that would provide the practical means for electronics equipment owners to repair their devices. Repair is legal under copyright law and patent law. However, owners and independent technicians are often unable to make their own repairs because of manufacturer limitations on access to repair materials such as parts, tools, diagnostics, documentation and firmware.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.
Emig is a surname.