BEGIN:VCALENDAR VERSION:2.0 PRODID:-//92.205.212.113//NONSGML kigkonsult.se iCalcreator 2.26.9// CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:en•co•tec X-WR-CALDESC:Consulting &\; Seminare für Medizinprodukte und IVD X-FROM-URL:https://www.encotec.at X-WR-TIMEZONE:Europe/Vienna BEGIN:VTIMEZONE TZID:Europe/Vienna X-LIC-LOCATION:Europe/Vienna BEGIN:STANDARD DTSTART:20231029T030000 TZOFFSETFROM:+0200 TZOFFSETTO:+0100 RDATE:20241027T030000 TZNAME:CET END:STANDARD BEGIN:DAYLIGHT DTSTART:20240331T020000 TZOFFSETFROM:+0100 TZOFFSETTO:+0200 RDATE:20250330T020000 TZNAME:CEST END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:ai1ec-7117@encotec.at DTSTAMP:20240328T193023Z CATEGORIES;LANGUAGE=de-DE:FH &\; Universitäten\,Gesundheitswesen\,IVD\,L abors\,Medizintechnik CONTACT: DESCRIPTION:In the function as a medical device advisor\, you perform a res ponsible activity that carries legally defined rights and obligations in A ustria. These national requirements remain as essential components of the new Medical Devices Act (MPG).\nIn this basic course for medical device co nsultants\, you will deepen your knowledge of the essential nationally and internationally valid legal foundations.\nAccording to the MPG\, manufact urers or a person or body appointed by them are obliged to provide regular training for medical device advisors (including proof of training). We su pport you in this!\nAfter successfully passing the online examination\, yo u will receive an en.co.tec certificate of participation.\nContent\n\nThe Austrian Medical Devices Act (MPG)\nRequirements for medical device adviso rs\nEU regulations for medical devices and in-vitro diagnostics (MDR and I VDR)\nCE marking\nClassification of medical devices and IVD\nLegal aspects of marketing & sales\nVigilance and Post Market Surveillance\nDefinitions and quality criteria\nCase studies\n\nCosts\n\nEarly bird (up to 4 weeks before the seminar): Euro 480\,- (excl. VAT)\nStandard (4 to 2 weeks befor e the seminar): Euro 530\,- (excl. VAT)\nLast Minute (less than 2 weeks be fore the seminar): Euro 560\,- (excl. VAT)\nincl. seminar documents as PDF and a certificate of participation.\n\nYour Trainer\nDI(FH) Dr. Andreas B öhler\, MLBT\nManaging Director R’n’B Consulting GmbH\, Lecturer Universit y of Applied Sciences Upper Austria – Software Lifecycle Processes / Opera ting Systems & IT Security\, Expert for Medical Software (EN 62304\, EN 62 366\, IEC 82304-1)\, Quality Management (EN-ISO 13485)\, Mobile Health (EN 62304\, IEC 82304-1) and Audits (according to EN ISO 19011)\nVenue: ONLIN E\nAll you need for our ONLINE seminars is a laptop with camera and microp hone. Our eLearning platform works on all operating systems in a web brows er (e.g. Firefox\, Safari or Chrome). You will receive the seminar documen ts and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar – i.e. you can ask your questions to the lecturer\, there will be practice examples and also the possibility to exchange ideas with the other participants.\nBook now! \nClick here for online registration.\nFor questions: office@encotec.at or +43 1 8863491\nTickets:https://encotec.at/anmeldeformular/. DTSTART;TZID=Europe/Vienna:20220517T090000 DTEND;TZID=Europe/Vienna:20220517T163000 LOCATION:ONLINE SEQUENCE:0 SUMMARY:Basics for Medical Device Advisors: Regulatory requirements accordi ng to MPG URL:https://www.encotec.at/Veranstaltung/medical-devices-advisor-regulatory -requirements-according-to-mpg/ X-COST-TYPE:external X-ALT-DESC;FMTTYPE=text/html:\\n\\n
\\nIn the function as a medical device advisor\, you perform a responsible activity that carries legally defined rights and ob ligations in Austria. These national requirements remain as essential comp onents of the new Medical Devices Act (MPG).
\nIn this basic course for medical device consultants\, yo u will deepen your knowledge of the essential nationally and international ly valid legal foundations.
\nAccordin g to the MPG\, manufacturers or a person or body appointed by them are obl iged to provide regular training for medical device advisors (including pr oof of training). We support you in this!
\nAfter successfully passing the online examination\, you will receive an en.co.tec certificate of participation.
\nDI(FH) Dr. Andreas Böhler\, MLBT
\nManaging Director
R’n’B Consulting GmbH\, Lecturer University of Applied Sciences Upper Aus
tria – Software Lifecycle Processes / Operating Systems & IT Security\, Ex
pert for Medical Software (EN 62304\, EN 62366\, IEC 82304-1)\, Quality Ma
nagement (EN-ISO 13485)\, Mobile Health (EN 62304\, IEC 82304-1) and Audit
s (according to EN ISO 19011)
All you need for our ONLINE seminars is a laptop with ca mera and microphone. Our eLearning platform works on all operating systems in a web browser (e.g. Firefox\, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room in time by emai l. The seminar will be interactive – similar to a face-to-face seminar – i .e. you can ask your questions to the lecturer\, there will be practice ex amples and also the possibility to exchange ideas with the other participa nts.
\nClick here for online registration.
\nFor questions: off ice@encotec.at or +43 1 8863491
\nTickets:https://encotec.at/anmeldeformular/.
X-COST:530\, X-TICKETS-URL:https://encotec.at/anmeldeformular/ END:VEVENT END:VCALENDAR