Risikomanagement fur medizinproduktesoftware nach iso 14971. He is a lecturer at the th nuremberg in the area of risk management and usability for medical devices and medical networks, and is a member of the association international certified professional for medical software icpmsb e. I had the pleasure of working with martin for more than one year at nxp in hamburg, collaborating and getting his professional support on several development projects. Risk analysis and risi management according to iso 14971 for medical devices and invitrodiagnostics en 1441 with software qware riskmanager, certification incl. Logicgate is the first agile enterprise risk management software that adapts as your business changes, allowing you to accurately identify, assess, and monitor business risks. Softwarerisikomanagement konform iso 14971 johner institut. Learn more about tuv rheinland group, the leading provider of technical services worldwide. Many translated example sentences containing risikomanagement nach iso englishgerman dictionary and search engine for english translations. Nilaykumar patel, msc quality and regulatory affairs. Press stay current with industry trends, testing and compliance requirements. Risikomanagement mdr fur medizinprodukte jetzt online. During almost 30 years of working in an accredited testing laboratory for medical electrical devices and electrical laboratory devices i was able to gain a lot of experience regarding the safety requirements and essential performance features of medical and laboratory devices. Translate texts with the worlds best machine translation technology, developed by the creators of linguee.
Stop relying on spreadsheets and email automate your enterprise risk management program with logicgates fully customizable risk management software. Risikomanagement nach iso 14971 english translation linguee. Quality management for the processing of medical devices. Kimies corporation has been a siemens digital industries software solution partner since 1997. The iso 14971 is the standard for the application of risk management for medical devices. Testing of wheelchairs, rollators and scoot mobiles testing of blood glucose monitors and pen injectors conformity assessment procedures according to the ec directives on medical devices, invitrodiagnostics and active implantable medical devices testing of wireless medical devices certi. The company provides product design management, product lifecycle management and application lifecycle management solutions and professional services to customers, primarily in the automotive, electronics, manufacturing and shipbuilding industries. Its rare that you come across a standout talent like martin. The company offers software tools for systems tests and complex and automated functions, as well as extensive test automation services. It describes a risk management process to ensure that the risks are known and dominated by medical and are acceptable when compared to benefits. Medizinsoftware softwareentwicklung fur medizinprodukte. Elisa beretta software test engineer inpeco linkedin.
Regulation eu 2017746 fundamentally changes the classification of in vitro diagnostic medical devices. Suregashalini ramarajan manufacturing project manager sw. Look up words and phrases in comprehensive, reliable bilingual dictionaries and search through billions of online translations. Methode risikomanagement hochleistungsorganisation. He participates in the development of marketing and sales measures and assesses usability and other important aspects in the context of product development. The mastercontrols risk management software systems insures that organizational risk tolerance is not exceeded. White paper verbesserung des risikomanagements fur. Here we combine medical professional knowhow with our software development expertise.
Risikomanagement nach iso english translation linguee. Forum risikomanagement medizinprodukte dietz consultants. Prosystem successful approval for medical devices in china. In accordance with directive 9879ec annex ii, in vitro diagnostic products were classified as products of list a highest risk, list b high risk, self testing or other in vitro diagnostic products. Jama software partners with tracetronic jama software. Martin kadner geschaftsinhaber hamburg applications me.
Md 1201 gerate mit ionisierenden strahlen devices utilizing ionizing radiation. Leitfaden itsicherheit fur medizinprodukte a metainformationen 1. Today, financial services organizations are pursuing a strategy that provides greater links between risk and performance. Sie wissen, wie sie risikoanalysen fur software erstellen. His expertise includes clinical trials and preclinical testing, research and development, and quality control for new products. China is one of the biggest markets of healthcare industry and is attractive for global medical device manufacturers. Software development of robotic control systems for medical applications. The software s standard methodology simplifies the application of resources in the most riskprone areas. Iso 14971 im risikomanagement nach iso 14971 unterstutzen wir sie mit fmea, pha oder fta. Development of an insilico simulation test environment for the design of algorithms used in software as a medical device nitsche patrick prof. Verbesserung des risikomanagements fur medizinprodukte.
Iso 14971 konformes risikomanagement polarion software. Design, implementation and testing of software components for robotic control system. Prosystem in vitro diagnostic regulation eu 2017746. Tracetronic provides solutions for automating the test and validation of ecu embedded systems in transport vehicles. Regulatory risk management wolters kluwer financial services. The integration of jama and tracetronic enables cohesive development and testing of requirements. Testverwaltung versionskontrolle traceability risikomanagement. Richtlinie uber medizinprodukte, klasse im messend, is steril, iia, iib, iii egkonformitatserklarung. Inhouse schulungen engineering think tank prozessberatung softwareengineering. Plato risk management 14971 plato ag solutions by software.
1273 904 1228 1557 1227 637 723 405 1446 803 545 811 676 259 992 305 884 503 372 412 305 1317 701 221 154 92 633 322