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Medical devices in spanish. europa. Página principal en español de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) DEVICE translations: aparato, dispositivo, recurso, artefacto, dispositivo, dispositivo [masculine], aparato [masculine]. May 26, 2021 · Malaysia’s medical device regulations are similar to the classification scheme used in the European Medical Device Directive (MDD) 93/42/EEC. We translate for pharmaceutical, medical devices, healthcare, biotech and CRO industries. c. Apr 25, 2023 · It regulates the need to obtain prior operating licences, which are to be granted by the Spanish Agency of Medicines and Medical Products (AEMPS), by any natural or legal person that manufactures, imports, group, or sterilise medical devices, as well as by any other facilities in which the above activities are carried out. However, genre theorists have not systematically studied either relationships among related Addressing people with the right form in Spanish (“tú” or “usted”) is extremely important for native speakers of Spanish. Jun 25, 2020 · It is essential to know as many of the top Spanish medical terms for nurses, doctors, & emergency/first responders in communities with Spanish speakers. Learn Spanish. Although it has a well established medical device industry, it’s healthcare system relies on imported products and offers therefore good opportunities for foreign manufacturers with a cost-efficient product offering. Genre studies have been mainly focused on the rhetorical structure of research papers. Decree 32780-S - Medical device registration, inspection, surveillance and control fees; DAJ-RM-1151-08 - Medical device equivalence procedure; Communiqué DAC-UPS-002-11 - Recognition of the United States medical device clearance and approval procedures; Class-, type- and procedure-specific documents and guidelines; Fig. Translate Medical equipment. andarín 6. Las herramientas — tools in Spanish — are objects you use to fix things or otherwise modify the environment. (medicine) a. Medical Device Recalls Introducción al retiro del mercado de dispositivos médicos: responsabilidades de la industria Introduction to Medical Device Recalls: Industry Responsibilities (Spanish We provide medical translation services for all specialised fields, including medical devices and software (user guides, user manuals, pharmacovigilance reports), pharmaceuticals (drug labels and inserts, clinical reports, drug registration documentation), clinical trials (questionnaires, patient records, FDA submission forms), biotechnology (patient information leaflets, patent reports) and WINMED NORDIC and WINMED SPAIN are part of a group of companies distributing medicines and medical devices to hospitals and pharmacies in Spain and the Nordic countries WINMED SPAIN is a Spanish company with Danish heritage and founded on extensive knowledge and experience in the pharmaceutical sector, both in Spain and internationally MEDICAL DEVICE IMPORTS MEDICAL DEVICE It is important to take in consideration the Spanish Medical Agency (AGEMED) requirements when you want to import medical device in Spain. Se está quedando sorda pero se niega a usar un audífono. Professional and certified medical translation services you can trust. ), infrastructure Search Medical device sales jobs in Spain with company ratings & salaries. Much like the post-market or post-market surveillance devices, medical device tracking devices are either going to be Class II or Class III-- again, the failure of which would reasonably have a Emerging medical device trends deal with tackling the risk of infections, leveraging health data, and automating manual processes. Medical device manufacturers are using technologies such as artificial intelligence (AI), analytics, robotics, and immersive technologies, among others. Many translated example sentences containing "medical" – Spanish-English dictionary and search engine for Spanish translations. medical assistance n (first aid) atención médica nf + adj Nov 21, 2007 · The present study aims at describing and comparing the rhetorical and phraseological structures of abstracts in English and Spanish in order to observe how information is rendered in the two languages under analysis. Learn more in the Cambridge English-Spanish Dictionary. Device classification in Chile. El artefacto nuclear fue cargado en el buque de guerra. S. HEARING AID translate: audífono, audífono. dispositivo, aparato, mecanismo are the top translations of "Device" into Spanish. 16 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of approximately 6% by 2026, one of the largest medical device markets in Latin America. SaMD is subject to the same regulatory requirements as other medical devices device translation in English - Spanish Reverso dictionary, see also 'bugging device, homing device, input-output device, anti-roll device', examples, definition, conjugation Translate Implanted devices. There are several amendments impacting different health supplies and in this document we will present a summary for those affecting Medical Devices: Translations . The import and distribution of medical devices in different countries are subject to strict approval processes, and compliance measures. Medical device classification in Ecuador. PALO ALTO, Calif. Need to translate "durable medical equipment" to Spanish? Here's how you say it. El hospital de campaña cuenta con un equipo médico moderno. dispositivo médico, material médico-quirúrgico, producto sanitario are the top translations of "medical device" into Spanish. el equipamiento médico. 1. The Institute’s affordable 8-week and 12-week programs offer students clinical knowledge, hands-on experience, consultative sales training, and career development. All medical devices must be registered with DIGEMID in order for manufacturers to be The Spanish Presidency of the Council of the European Union held the 53rd meeting of the EU Competent Authorities for Medical Devices (CAMD) on the 19-20 of September 2023, in Santiago de Compostela, Spain. When protective clothing or devices are worn on portions of the body and a monitoring device is required, at least one such monitoring device shall be utilized as follows: a. Medical devices for short-term use, continuous use for a period of up to 30 days. The Spanish Agency of Medicines and Medical Devices (Spanish: Agencia Española de Medicamentos y Productos Sanitarios; AEMPS) is a regulatory and autonomous agency of the Government of Spain that acts as the highest sanitary authority in the country in terms of medical safety on medicines, health products, cosmetics and personal care products. The aim of this paper is to analyze the sustainability and performance of the maintenance of electro-medical equipment, through several healthcare variables (hospital admissions, surgeries, consultations, etc. 53 open jobs for Medical device sales in Spain. 4725 of 2005, Article 57 Labels, tags and packaging of imported medical devices Translation of "medical device" into Spanish . Languages in Contrast 7/1, 1-28. . If you or someone in your household requires the regular use of electrically powered medical equipment or other qualifying medical devices, you may be eligible for our Medical Baseline Allowance program. See 6 authoritative translations of Medical in Spanish with example sentences, phrases and audio pronunciations. 00 billion. GTS has completed translation projects for some of the world’s leading medical device companies. Before this announcement, the Ministry of Health required that any submission must be presented in Spanish. It replaces the provisions of Royal Decree 1591/2009 on medical devices and of Royal Decree 1616/2009 on implantable medical devices. The new Royal Decree 192/2023, of 21 March 2023, which regulates medical devices (RDPS) complements the application of the provisions of Regulation (EU) 2017/745, on medical devices (MDR) in Spain. medical aid n (emergency medical help) asistencia médica nf + adj : ayuda sanitaria nf + adj : The charity is providing medical aid for victims of the flood. El equipamiento médico está en la ambulancia. medical director. See Google Translate's machine translation of 'medical devices'. peatón 7. Medical Spanish Dictionary. . Over 100,000 Spanish translations of English words and phrases. Devices include equipment used for mobility, per a licensed medical practitioner. We provide certified Spanish medical localizations, covering drug insert translation, IFU (information for use) documents translation, medical device manuals translation, clinical studies translation, medical patent localization, and clinical trial linguistic validation. Describing Phraseological Devices in Medical Abstracts: An English/Spanish Contrastive Analysis. The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) 2017/45 of the European Parliament and the Council of 5 April 2017 on medical devices. In other words, any manual, test or clinical reports must be translated. The Medical Devices market worldwide is projected to grow by 5. For example, in the case of adults, the correct form will be interpreted as a sign of respect, while but choosing incorrectly will be perceived as disrespectful, and may hinder the establishment of a good provider Mar 27, 2023 · In brief. Mar 28, 2023 · Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. el instrumental médico. 16 Medical devices; Spanish-language version of certain required statements. Interference with sensitive medical equipment is addressed in the context of electromagnetic compatibility and the legislation governing medical devices. medical doctor. caminante 3. Colombia — like Argentina, Brazil, Paraguay, and Uruguay — is a full member of Mercosur (official Southern Common Market), a South American trade bloc established in 1991 used to promote free trade and fluid Jul 9, 2023 · Software as a Medical Device (SaMD): COFEPRIS recognizes that certain software or digital health applications can be classified as medical devices if they are intended for medical purposes and have a direct impact on patient diagnosis, treatment, or monitoring. Based in Madrid, MedLumics is backed by Ysios Capital, Innogest Capital, Caixa, Seroba Life Sciences and Andera Partners. Jun 18, 2001 · Medical devices transient use: intended for continuous use for less than 60 minutes. We have many years' experience with Chile medical device classification. ↔ Contáctese con la línea de servicio al cliente adecuada si el dispositivo no funciona apropiadamente. medical disability. Translate Durable medical equipment. Sample translated sentence: Contact the appropriate customer service helpline if the device does not operate properly. Jul 29, 2022 · This permit is issued by the Spanish Agency of Medicine and Medical Devices (AEMPA). Decree no. Anyone who uses certain medical devices or needs space heating or air conditioning because of a medical condition may qualify. Medical Device Reimbursement in Spain. The main administrations in charge of public health and reimbursement of medicinal products in Spain are: the Spanish Agency of Medicines and Medical Devices (“AEMPS”), the Ministry of Health (“MOH”), particularly the General Directorate of Pharmacy (“DGCC”), the Inter-Ministerial Commission of Prices of Medicinal Products (“CIPM Jul 12, 2023 · Medical device market in Argentina is estimated to reach $6. In accordance with the prior public consultation, the new Spanish regulation will address, among other issues, the following: Apr 19, 2024 · It acts as the self-regulatory body of all medical devices companies that have adopted its Code of Practice (“FENIN Code”), which regulates the interaction of the medical devices industry with HCPs, HCOs and POs as regards medical devices. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under § 801. Communicate and assist with medical professionals. Jan 19, 2019 · The institution responsible for medical device regulations in Spain is Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a state agency within the Spanish Ministry of Health, Social Services and Equality. This program provides an additional 16. This reflects the positive growth and promising prospects within the industry, highlighting the increasing demand for medical devices in the country. b. The official definition of a tool is a device or implement, especially one held in the hand and used to carry out a particular function. Heating pads; Humidifiers; Pool or tank heaters; Saunas or hot tubs; Vaporizers; Whirlpool pumps Note: Qualifying medical devices include any medical device used to sustain life. 801. Many translated example sentences containing "implanted medical devices" – Spanish-English dictionary and search engine for Spanish translations. Medical devices for long-term use for more than 30 days. medical dispensaries. Our graduates enjoy a 84% job placement rate. Methinks Many translated example sentences containing "wheelchairs and walkers" – Spanish-English dictionary and search engine for Spanish translations. Apr 30, 2020 · There are also 64 countries without a regulatory agency governing the registration of medical devices. As a result of the development and expansion of the EU market and the requirement for the CE mark, many U. See 2 authoritative translations of Hearing aid in Spanish with example sentences and audio pronunciations. Stepes’ ISO 13485-certified medical device translation solutions are technology-enabled to streamline the localization process for digital health devices, implantable devices, surgical devices, imaging systems, diagnostics, medical equipment, wearable devices, and remote monitoring systems to deliver measurable linguistic and technical quality and accuracy. Determining the classification for your medical device might be challenging and is critical to ensure a smooth registration process. Some implantable devices require the implant card. Mar 30, 2023 · In brief Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on March 22. Thanks. May 8, 2024 · As a result of the approval of the new Royal Decree 192/2023 of 21 March, which regulates medical devices, new specific regulation on the advertising of medical devices is currently being discussed. The medical device classification in Chile is based on rules. Jul 31, 2023 · In 2023, the Medical Devices market in Colombia is expected to achieve an impressive revenue milestone of US$2. el equipo médico. 16, 2021 /PRNewswire/ — Pocketalk, the global leader in connecting conversations and removing language barriers, today announced it has become the first HIPAA-compliant handheld The new Royal Decree 192/2023, of 21 March 2023, which regulates medical devices (RDPS) complements the application of the provisions of Regulation (EU) 2017/745, on medical devices (MDR) in Spain. Ecuador's medical device classification is risk- and rule-based. Translate Medical device. Lorés, Rosa 2004. Translation for 'medical device' in the free English-Spanish dictionary and many other Spanish translations. (device worn by the hard of hearing) audífono nm : She's growing deaf, but refuses to wear a hearing aid. The entry into force in Spain in March 2023 of a new regulation on medical devices (MD) (Royal Decree 192/2023, of 21 March 2023 on medical devices, called “Spanish Decree on MD”) is the most important new development that has occurred this year. English to Spanish Medical Dictionary; Spanish to English Medical Dictionary; Click on one of the above medical Spanish dictionaries to look up Spanish medical terminology. Translations include coloquial usage, and all terms inlcude audio. We recognize certain needs require increased energy use and offer this program to help reduce your monthly bill. eu Las interferencias con productos sanitarios sensibles se abordan en el marco de la compatibilidad electromagnética y la legislación relativa a los dispositivos médicos. Learn more in the Cambridge English-Spanish The Medical Sales College has prepared thousands to land their dream job in the medical device sales industry for more than a decade. Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on 22 March 2023. Identify and utilize basic medical supplies. (ES, coloquial) sonotone nm : Se está quedando sorda pero se niega a usar un sonotone. The Americas and the Caribbean The Americas can be covered with four languages – English, French (Canadian), Portuguese (Brazilian) and Spanish. Objectives: Electro-medical equipment generates a high impact on the sustainability of a hospital and require high availability at a reasonable maintenance cost. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. marchador 5. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kinds of products and introduces provisions regarding Jun 25, 2020 · Founded in 2011, this medical device development startup raised €34m in Series B funding in 2017, to develop hardware to treat atrial fibrillation patients, who experience irregular heartbeat rhythm. Spanish Translation of “MEDICAL DEVICE” | The official Collins English-Spanish Dictionary online. Contrasting the Rhetoric of Abstracts in Medical Discourse: Implications and Applications for English Spanish Translation. companies have been centralizing their manufacturing and import operations into one single EU country from which they register and distribute their Mar 24, 2023 · The new Spanish Medical Devices Regulation (Spanish MDR) aims to bring domestic regulations on medical devices in line with Regulation (EU) 2017/745 of the European Parliament and of the Council Translate Device. (5) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection Mar 10, 2020 · As expected, the idea is to repeal the Royal Decrees currently in force and bring together in a single legal text the provisions relating to medical devices and active implantable medical devices. Many translated example sentences containing "medical devices" – Spanish-English dictionary and search engine for Spanish translations. Agencia Española de Medicamentos y Productos Sanitarios Spain, having almost 50 million inhabitants, has one of the larger medical device markets in Europe. noun. Devices are for home-use only. Feb 14, 2012 · Spanish Vocabulary: Medical – General Supplies el vocabulario español: médico – los suministros generales. … The Spanish current regulatory framework regarding authorization, pric-ing and reimbursement of medical devices includes (i) Spanish Law on Medicinal Products, (ii) Royal Decree 1591/2009, on medical devices, (iii) Royal Decree 1616/2009, on active implant medical devices, and (iv) Royal Home » Learning Resources » Medical Spanish Dictionary. andador 2. paseante 4. Sample translated sentence: Medical devices — Application of usability engineering to medical devices ↔ Dispositivos médicos. A Proven Track Record in Medical Device Translation Projects. 70bn in 2029. With a thriving healthcare sector and a growing emphasis on advanced medical technologies, Colombia presents a favorable medical aid n (insurance for medical care) seguro médico nm + adj : Medical aid will cover the cost of any medicines you need. The new Royal Decree identifies the competent authority in Spain for medical devices, expands the scope of some of the provisions to new kind of products and introduces provisions regarding the manufacture of in-house products and Examples of medical devices that don't qualify. Use these 149 terms commonly used terms in healthcare in order to understand the language and communicate better with patients in case of a medical emergency or routine attention. Mar 28, 2023 · In brief. device n (bomb) artefacto nm : The nuclear device was loaded onto the battleship. López Arroyo, Belén / Méndez Cendón, Beatriz 2007. See 3 authoritative translations of Medical equipment in Spanish with example sentences and audio pronunciations. medical discharge. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. pollera Jul 19, 2021 · The Most Comprehensive List of Tools in Spanish. Their technology is particularly adept at evaluating patients who are unable to actively participate in their own visual health examinations, streamlining the process for healthcare providers. The CCPS portal is only available in Spanish. Product Registration. Jun 26, 2023 · The healthcare sector, being a dynamic and rapidly developing industry, relies heavily on medical devices to support diagnosis, treatment, and patient care. ANEFP is the Spanish OTC industry association. Translate Hearing aid. Feb 22, 2019 · Class I medical devices are associated with the lowest risk and class III medical devices are associated with the highest risk. Translation. Feb 28, 2019 · Class II — Moderate risk medical devices; Class III — High risk medical devices; Class IV — Critical risk medical devices; With RegDesk Alerts you can always track changes and we warned when something changed in regulatory of Peru. Jul 6, 2021 · In brief. In the meantime, the regulation foreseen in this matter in Royal Decree 1591/2009 of 16 October on medical devices remains in force. (M) The medical equipment is in the ambulance. 68% (2024-2029) resulting in a market volume of US$669. You must have a qualifying medical condition or use qualifying medical equipment. The complete formal review and final inclusion in the Spanish database might take up to 6 months. Meta 52/3, 503-516. Many translated example sentences containing "device" – Spanish-English dictionary and search engine for Spanish translations. When an apron is worn and only one monitoring device is in use, the device shall be worn at the collar outside the apron. … Localization of medical device software, translation of resource files; Click here to access a page with free translations of the most common EN 980:2008 labels used in medical device IFUs. Aug 23, 2021 · Pocketalk innovation and tech yields extraordinary experience for patients, tremendous cost savings for healthcare providers and reduces reliance on costly third-party translation services. Jan 14, 2011 · What is the correct term for a walker for an older person? I got a few words on the tranlator and I was wondering which one is correct. PDF version Date of publication: July 16th, 2012 Category: AEMPS, HUMAN MEDICINAL PRODUCTS, CLINICAL RESEARCHReference: MUH, 12_vi/2012 Versión en español The Voluntary Harmonisation Procedure is an efficient tool to achieve harmonised and quick approvals of The notification process, for medical and IVD devices, takes 2 – 3 months after submission of documents until receiving a communication from the Spanish Authority that the legal requirement has been met and the product can be distributed. device n (artistic, poetic technique) recurso nm With over 30 years of experience delivering medical translation services for pharmaceutical companies, biotechnology firms, clinical research organizations (CROs), medical device manufacturers, hospitals, public health institutions, private practices, non-profit health groups, and more, we are prepared to provide precise Spanish medical Jan 9, 2019 · There are currently ten harmonized medical device resolutions for Mercosur countries, including procedures for GMP certification, the training of inspectors, premarket approval, the safety and efficacy of medical devices, and the exchange of information regarding inspection dossiers and incidents leading to death or serious health detoriations. Este aparato futurista barre los pisos por sí solo. medical disorder. Jul 23, 2023 · When the medical device or biomedical equipment of controlled technology has an insert, this shall contain, in Spanish, sufficient information to ensure the proper performance of the procedure and safe use. (M) The field hospital has a modern medical equipment. la. device n (gadget, machine) aparato, artefacto nm : This futuristic device sweeps the floors by itself. Identification of comparable products in the national benefits package and Spanish DRGs, applications for reimbursement or add-on funding by the Autonomous Communities (Comunidades Autónomas). Translation of "Device" into Spanish . The first step that must be follow is to get the medical device import license, without it , we won’t be able to import those kind of products. Discussions about 'medical devices' in the English Only forum Go to Preferences page and choose from different actions for taps or mouse clicks. Like all the Countries of the European Union, Spain will also adopt the New Regulation (EU) 2017/745 on Medical Devices. Mar 22, 2024 · Sec. Oct 27, 2023 · DIVE Medical: DIVE Medical’s expertise lies in creating diagnostic devices that make visual health assessments both quick and precise. Translate Medical. 15(c). 5 kilowatt-hours (kWh) of electricity per day. These are not covered in this article. The website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is constantly updated in Spanish and English. See 7 authoritative translations of Device in Spanish with example sentences, phrases and audio pronunciations. With its position as the second-largest medical device market in Latin America, Mexico presents a lucrative opportunity for manufacturers in the IVD and medical device industry. Medical devices are products or equipment intended for a medical purpose. eur-lex. See Spanish-English translations with audio pronunciations, examples, and word-by-word explanations. How To Qualify . English-Spanish translation of "MEDICAL DEVICE" | The official Collins English-Spanish Dictionary with over 100,000 Spanish translations. , Aug. Have a look at the English-Tajik dictionary by bab. 3. Feb 8, 2023 · In order to comply with the provisions of the EU Medical Device Regulation (EU MDR) and the (coming) Spanish MDR, the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicinal Products and Medical Devices, AEMPS) has recently renewed the application procedure for the authorization of clinical investigations with medical devices in Spain. jtnct ecwpwzk tnahq wmwu egyc twsdf izh bfzu nvg brjfu