Bis zu 80% Rabatt bei Agoda.com. Bewertungen lesen und vergleichen Englisch-Deutsch-Übersetzungen für medical device im Online-Wörterbuch dict.cc (Deutschwörterbuch) Lernen Sie die Übersetzung für 'medical device' in LEOs Englisch ⇔ Deutsch Wörterbuch. Mit Flexionstabellen der verschiedenen Fälle und Zeiten Aussprache und relevante Diskussionen Kostenloser Vokabeltraine Als Device Master Record (DMR), auf Deutsch oft als Produktstammakte genannt, bezeichnet man eine Zusammenstellung von Berichten, welche die genaue Beschreibung eines medizintechnischen Gerätes sowie alle Anweisungen für dessen Produktion, Handhabung und Wartung beinhalten.Der durch die FDA (die US-amerikanische Food and Drug Administration) geprägte Begriff ist Teil der Quality System.
Viele übersetzte Beispielsätze mit device master file - Deutsch-Englisch Wörterbuch und Suchmaschine für Millionen von Deutsch-Übersetzungen Viele übersetzte Beispielsätze mit mobile medical device - Deutsch-Englisch Wörterbuch und Suchmaschine für Millionen von Deutsch-Übersetzungen
Die Verordnung (EU) 2017/745 über Medizinprodukte ist am 25. Mai 2017 in Kraft getreten. Sie wird auch Medical Device Regulation (MDR) oder europäische Medizinprodukte-Verordnung genannt. Sie gilt in den Mitgliedstaaten der Europäischen Union unmittelbar und muss daher nicht in nationales Recht umgesetzt werden. Gleichwohl werden umfängliche Anpassungen des nationalen Medizinprodukterechts. The medical device file for each type or model of medical device referred to in ISO 13485:2016, clause 4.2.3 could be referred by different names, for example, technical file, design history file, device master record, device history file etc. and is up to the organization to define which of these documents constitutes their medical device file Schlagwort: Medizinprodukterichtlinie 93/42/EWG (Medical Device Directive MDD) Die Medizinprodukterichtlinie (Richtlinie 93/42/EWG des Rates), englisch Medical Device Directive, oft als MDD oder 93/42/EWG bezeichnet, ist eine von drei europäischen Richtlinien für Medizinprodukte. Diese Richtlinie — wie alle anderen — müssen die europäischen Staaten in nationales Recht überführen, was.
Medical Device Services ist für biologische und mikrobiologisch-hygienische Prüfungen nach EN ISO/IEC 17025 und Richtlinien 93/42/EWG, 90/385/EWG (für Medizinprodukte) akkreditiert durch die Deutsche Akkreditierungsstelle (DAkkS, D-PL-13392-01). Urkunde Geltungsbereic dict.cc | Übersetzungen für 'medical device' im Polnisch-Deutsch-Wörterbuch, mit echten Sprachaufnahmen, Illustrationen, Beugungsformen,. Gynäkologie. Inkontinenzprodukte. TVT - O 325 TVT - Classic 325 TVT - Abbrevo 325 TVT - Exact 326. Adhäsionsprophylaxe. Interceed 32
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. ) Language: PDF: HTML: BG: MDR_BG: MDR_BG: ES: MDR_ES: MDR_ES: CS: MDR_CS : MDR_CS: DA: MDR_DA: MDR_DA: DE: MDR. Über 7 Millionen englische Bücher. Jetzt versandkostenfrei bestellen Der kostenlose Service von Google übersetzt in Sekundenschnelle Wörter, Sätze und Webseiten zwischen Deutsch und über 100 anderen Sprachen Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand alone software - MEDDEV 2.1/6: Download native rendition (514.169921875) Download PDF rendition (516.07421875 Medical Device - Full Definition 'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of
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. The Medical Devices Directives establish specific procedures that national authorities must follow when considering the enforcement of the harmonised legislation. In addition, the Medical Device Vigilance System aims at preventing the repetition of incidents related to the use of a medical device For a device master record (DMR), I recommend creating a DMR Index using a template that is organized in accordance with an international standard to meet the needs of a DMR and a Technical File. However, the DMR is a living document that only shows the most current design outputs for a device while a DHF may require repeating various verification and validation testing if the initial design. Medical devices. The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file) Coronavirus (COVID-19) and Medical Devices Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields.
BSI Medical Devices offer training courses to support you in the product lifecycle, ensure you stay compliant with industry regulations for global market acces Unknown Device Identifier 9.01 Englisch: Der Unknown Device Identifier ist ein detaillierter Gerätemanager, mit dem die Suche nach dem richtigen Treiber vereinfacht wird 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 a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation. Reference
The members are Notified Bodies under any or all of the three medical device directives: 90/385/EEC; 93/42/EEC; 98/79/EC. Members exclusive access. Skip to content. Search for: Home; About us; Members; Links; Presentation; Question/Contact; Private part; Logout; Search for: Home PascalePerspectives 2019-01-22T15:12:22+00:00 Team-NB Documents. NB-MED documents. LATEST NEWS. Team-NB committee. Design History File - Medical Device Quality Systems Manual Section 3, Design Control: Design and Development of Products and Processes: 1: May 25, 1999: R: Implementing Design History Documents/ Technical Documents in the QMS: ISO 13485:2016 - Medical Device Quality Management Systems: 3: Sep 6, 2019 : N: Design Validation Conventions for Design History Files: 21 CFR Part 820 - US FDA Quality. An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA).. Medical Detectives - Geheimnisse der Gerichtsmedizin (Originaltitel: Medical Detectives, später Forensic Files) ist eine US-amerikanische Krimi-Dokumentation, die von 1996 bis 2011 erstausgestrahlt wurde.Für die ersten vier Staffeln lief die Serie auf TLC, wechselte dann für die weiteren zehn Staffeln zum Sender truTV (ehemals Court TV) Device master record (DMR) and design history file (DHF) records must be available for quality audit by the FDA at any time, and backed up and retained for a minimum of 2 years. The fluid nature of spreadsheets does not lend itself to the level of organization and accountability required in the medical device industry
Englisch-Deutsch-Übersetzungen für registered im Online-Wörterbuch dict.cc (Deutschwörterbuch) On 15 July 2016, the European Commission updated MEDDEV 2.1/6 (the MEDDEV Guidance), its medical device guidance on the qualification and classification of stand alone software used in the healthcare setting. The updated version replaces an earlier version of MEDDEV 2.1/6 issued by the European Commission in January 2012
Essential Requirements - General Safety and Performance Requirements. The Medical Device Directive (MDD) defines the essential requirements, as the requirements that every medical product has to fulfill, according to the scope they belong to.These essential requirements are described by Directive in Annex I. The Medical Device Regulation (MDR) continues this approach with the general safety. Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients. You will be leaving the Cook Medical website that you were viewing and going to a Cook Medical website for another region or country. Not all products are approved in all regulatory jurisdictions. The product information on these websites is intended only. .S. alone, medical devices are suspected of having caused the deaths of more than 80,000 people in the last decade. Authorities in the U.S. have collected 500,000 reports in 10 years on implants that had to be surgically removed because they no longer worked or had harmed patients. Still, the U.S. market is better regulated than in Germany. In the European. Lifecycle of a Medical Device / IVD Speaker ― Sally Jennings Chair, TARSC, IVD Australia . Disclaimer. Any comments, issues, actions or decisions described in or with this presentation DO NOT in any way reflect on any device currently or previously supplied on the market. Examples used DO NOT imply any action or decision on the part of any sponsor, manufacturer or the TGA. Clinical Evidence.
Medical device types and their associated regulation. The 2 main medical devices and their associated regulations are: general medical devices: The EU Regulation on Medical Devices 2017/745; in. Medical Device Directive: What remains unchanged? The changes are significant. Nevertheless, some core concept remained unchanged: No regulatory authority/agency: There won't be a European agency granting market access comparable to the European Medicine Agency EMA for drugs or the FDA for drugs, medical devices and more.; Manufacturers still declare conformance (with the CE mark) after. Materialise OrthoView offers the latest innovations driven by surgeons since 2002: for primary and revision hip and knee arthroplasties as well as shoulder and small joint replacements, fracture management, deformity correction and spine procedures
medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/ risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing. The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.. If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:. prepare the technical documentation before placing a. The Medical Devices Directives variously require in different Annexes that where a Notified Body has been involved in the approval of the quality system or the device design / type, the manufacturer must inform the Notified Body of any plan of substantial changes to : the quality system and/or the product-range covered by the quality system and/or the device which could affect compliance. Deutsch; Español; Français ; 简体中文 Be agile to meet changes in medical device label regulation, pricing or process with BarTender's Intelligent Templates™. Edit a label's data, format or design — updates occur immediately throughout your organization. Your medical device label is ready to print, in real time, anywhere it's needed, throughout the world. Support for your. The development of medical devices often spans multiple engineering domains such as software, mechanical, electrical, and fluidic systems as well as biomedical data analysis. Beyond basic development, the medical device design process also encompasses verification and validation activities that ensure the device meets specifications and complies with international regulations and standards.
Tag: medical devices. Make the most of AWS re:Invent 2020 - Life Sciences Attendee Guide by Kelli Jonakin, Ph.D. | on 12 NOV 2020 | in AWS re:Invent, Events, Industries, Life Sciences | Permalink | Comments | Share. AWS re:Invent routinely fills several Las Vegas venues with standing-room only crowds, but we are bringing it to you with an all-virtual and free event this year. This year's. Teleflex Medical Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. 2 07/07/2014 Teleflex Medical Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor. 2 07/07/2014 Teleflex Medical Market Access. With the exception of custom-made devices and medical devices manufactured in-house, medical devices pursuant to § 11, paragraph 1 MPG (Act on Medical Devices), as well as medical devices intended for clinical investigation, or in vitro diagnostic medical devices intended for performance evaluation, medical devices may only be placed on the market or put into service if they.
Acts as subject matter expert for medical device electronics. Creates and maintains the design history file owned by the Engineering department. Monitors, plans and manages changes of electronics as part of our product's life-cycle management. Conducts product component verification. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A. Medical Devices; Databases - 271 to 280 of 500 Results * Recall Date to: 07/27/2014 < 23 24 25 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski. Hinweise des BfArM zur Verwendung von Mund-Nasen-Bedeckungen, medizinischen Gesichtsmasken sowie partikelfiltrierenden Halbmasken (FFP1, FFP2 und FFP3) im Zusammenhang mit dem Coronavirus (SARS-CoV-2 / Covid-19). Im Zusammenhang mit der aktuellen Situation zu SARS-CoV-2 / Covid-19 werden in unterschiedlichen Zusammenhängen verschiedene Typen von Masken zur Bedeckung von Mund und Nase genutzt The European Union's proposed medical device regulation (MDR) will soon replace the EU's Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC), and is likely to result in important changes for medical device manufacturers
Attaching Files. Acceptable file formats for online submission include PDF (preferred), MS Word 97-2003 (.doc), MS Excel 97-2003 (.xls), TXT, TIFF version 6 (compressed), JPG, AVI, and MPEG. Users can attach up to a total of 10Mb of files each time they click Add attachment Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA). Brazil's base regulations and medical device classification schemes are similar to those found in the European MDD 93/42/EEC DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems. Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - PDF (734kb) Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form - DOCX (139kb) 21 September 2017: 18: IMDRF/SaMD WG/N41 FINAL:2017 : Software as a Medical Device (SaMD): Clinical Evaluation - PDF (1.10Mb) Software as a. Complaint Files and Medical Device Reporting. Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event. A complaint is.
medical files and would be available to them if requested. The industry journal could be used to alert the health professionals of their responsibility in this area. Below is a sample of a statement provided by Addenbrookes Maxillofacial Unit, containing all of the elements needed in the statement, which could be used by a maxillofacial manufacturer. MHRA Examples of statements for custom-made. In contrast, ISO 14971 is the standard for Application of risk management to medical devices . It describes a risk management process designed to ensure that the risks associated with.
A medical device classification system is therefore needed, in order to channel medical devices into the proper conformity assessment route. In order to ensure that conformity assessment under the Medical Device Directive functions effectively from January 1995, manufacturers should be able to know as early as possible in which class their product is. Identification of the class of each. BfArM's recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom (Current note/update from 2019.02.18)For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective. medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in §820.30(a)(2). This regulation does not apply to manufacturers of.
What is a medical device? How do medical devices come onto the market? How do you recognise a medical device? Based on examples, our videos answer these and a number of other questions. Medical devices: List of Field Safety Corrective Actions (FSCA) and recalls. Swissmedic monitors all safety measures and recalls for medical devices that are manufactured or marketed in Switzerland. Swissmedic. For the first time in the history of MEDICA, the world-leading medical trade fair, and the industry's number one platform for the suppliers of the medical technology industry, COMPAMED, held from 16 to 19 November 2020, took place entirely online due to the pandemic - but still won over their audiences due to their high degree of international resonance in this format too, as virtual.MEDICA.
Asus Aura ist ein Tool, mit dem sich die LED-Beleuchtung kompatibler Hardware steuern lässt. Freeware, kostenloser Download Bitte immer nur genau eine Deutsch-Englisch-Übersetzung eintragen (Formatierung siehe Guidelines), möglichst mit einem guten Beleg im Kommentarfeld. Wichtig: Bitte hilf auch bei der Prüfung anderer Übersetzungsvorschläge mit! Limited Input Mode - Mehr als 1000 ungeprüfte Übersetzungen! Du kannst trotzdem eine neue Übersetzung vorschlagen, wenn du dich einloggst und andere Vorschläge. SUBCHAPTER H - MEDICAL DEVICES: PART 820 -- QUALITY SYSTEM REGULATION. Subpart M - Records Sec. 820.198 Complaint files. (a) Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: (1) All complaints are processed in a uniform. Announcer: Welcome to The Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies. Jon Speer: What you say your product does, how you describe where your product is to be used are very important details with respect to.
assistance of a medical device, they must step to the chair (not included if the patient is wheeled in a standing lifter device). 6 Marching on spot (at bedside) Able to walk on the spot by lifting alternate feet (must be able to step at least 4 times, twice on each foot), with or without assistance. 7 Walking with assistance of 2 or more people Walking away from the bed/chair by at least 5. Information on submission of a request for authorisation of a clinical trial or a performance evaluation study Information on submission of a request for authorisation of a clinical trial or a performance evaluation study to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with Section 22a of the German Act on.
Medical Editorial: Since a wave of megamergers swept the medical device and diagnostics industry over the past couple of years, there has been a lot of change on medtech's leaderboard. Keep track of who's on top with our 2015 ranking of medical device and diagnostic players by total revenue. Information includes company name, total revenue for the last 12 months, market capitalization, 52-week. Medical Device CE marking. For more than 20 years, CEpartner4U has been a valued partner of hundreds of organizations worldwide. Our services range from regulatory strategy and compliance to clinical evaluation, authorized representation (EC REP), and training. Cepartner4u CEpartner4U as Representative. All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within. Medical devices > Field safety corrective actions (FSCA) Legal matters, standards. Legal matters. Legal Framework; Penal Law; Pharmacopoeia; Contact | Support & Help. General questions. Questions reg. medical devices; Media inquiries; Access to official documents; Feedback form; Support eGov services; Search Languages. DE; FR; IT; EN; Service navigation . Media; Job vacancies; eGov portal. SUBCHAPTER H - MEDICAL DEVICES : PART 820: QUALITY SYSTEM REGULATION Subpart A - General Provisions § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. Subpart B - Quality System Requirements § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. Subpart C - Design Controls § 820.30 - Design controls. Subpart D - Document Controls § 820.40.
Die U.S. Food and Drug Administration, abgekürzt FDA, deutsch US-Behörde für Lebens- und Arzneimittel, ist die Lebensmittelüberwachungs- und Arzneimittelbehörde der Vereinigten Staaten.Als solche ist sie dem amerikanischen Gesundheitsministerium unterstellt. Die FDA wurde 1927 gegründet und ist in White Oak angesiedelt nahe der Stadt Silver Spring im US-Bundesstaat Maryland to medical device manufacturers 1 Introduction This document gives guidance to Notified Bodies on auditing of a manufacturer's purchasing controls, including when and to what extent audits of suppliers are necessary. It also serves as guidance to Designating Authorities assessing such Notified Body activities. The manufacturer that is ultimately responsible for the device also has full. The European Union Medical Device Regulation of 2017. If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply