BEGIN:VCALENDAR VERSION:2.0 PRODID:-//PYVOBJECT//NONSGML Version 1//EN BEGIN:VTIMEZONE TZID:Europe/Stockholm BEGIN:STANDARD DTSTART:20001029T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10 TZNAME:CET TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20000326T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=3 TZNAME:CEST TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:20261028T212646Z - 66111@odoo-54dc9f858c-c7xvh DTSTART;TZID=Europe/Stockholm:20260929T093000 DTEND;TZID=Europe/Stockholm:20260930T160000 CREATED:20261028T212646Z DESCRIPTION:Quality Management System according to EN ISO 13485:2016 - in pract ice\nEstablishing an effective Quality Management System (QMS) is cruc ial for most organization​s in the medical device supply chain. For some markets\, it is even a must. The harmonized EN ISO 13485:2016 standard of fers a structured way to successfully establish such a QMS\, fulfilling ap plicable sections of both Medical Device Regulations (MDR 2017/745 and IVD R 2017/746) This course explains the requirements of the standard in a cle ar and coherent way and exemplifies its interpretation and application in different kinds of organizations. The course provides a basic understandin g of the requirements and how to design\, deploy\, and maintain a working QMS. From the programISO 13485 – History\, purpose\, scope and future QM S – The big picture\, CE-markingRelationship with ISO 9001 and MDR/IVDRR elationship with other Management System Standards and legal requirementsD etails of requirements and interpretation of EN ISO 13485:2016Challenges a nd best practices Target group This course is intended for personnel worki ng with quality assurance\, product development\, production and managemen t\, including internal auditors\, process owners\, and regulatory staff at companies within the medical device supply chain. Educational goals After the course\, participants will have a basic understanding of the standard and how to establish and maintain a QMS based on it. Prior knowledge A ba sic knowledge of management systems and experience from the medical device domain is recommended. Course presentation and language Course material i s in English. The course is held in Swedish or English\, as specified next to each course date. Course Leader The course is conducted in collaborati on with Aurevia. Please note: Intertek operates under strict standards of independence\, impartiality\, and integrity. Read more about how we work h ere: https://www.intertek.com/about/co​mpliance-governance/ Upcoming [.. .] DTSTAMP:20261028T212646Z LOCATION:Intertek Semko AB\, Torshamnsgatan 43\, Kista 16440\, Sweden SUMMARY:Quality Management System according to EN ISO 13485:2016 - in pract ice X-ALT-DESC;FMTTYPE=text/html:Quality Management System according to EN ISO 1348 5:2016 - in practice\nEstablishing an effective Quality Management Sys tem (QMS) is crucial for most organization​s in the medical device suppl y chain. For some markets\, it is even a must. The harmonized EN ISO 13485 :2016 standard offers a structured way to successfully establish such a QM S\, fulfilling applicable sections of both Medical Device Regulations (MDR 2017/745 and IVDR 2017/746) This course explains the requirements of the standard in a clear and coherent way and exemplifies its interpretation an d application in different kinds of organizations. The course provides a b asic understanding of the requirements and how to design\, deploy\, and ma intain a working QMS. From the programISO 13485 – History\, purpose\, sc ope and future QMS – The big picture\, CE-markingRelationship with ISO 9 001 and MDR/IVDRRelationship with other Management System Standards and le gal requirementsDetails of requirements and interpretation of EN ISO 13485 :2016Challenges and best practices Target group This course is intended fo r personnel working with quality assurance\, product development\, product ion and management\, including internal auditors\, process owners\, and re gulatory staff at companies within the medical device supply chain. Educat ional goals After the course\, participants will have a basic understandin g of the standard and how to establish and maintain a QMS based on it. Pri or knowledge A basic knowledge of management systems and experience from t he medical device domain is recommended. Course presentation and language Course material is in English. The course is held in Swedish or English\, as specified next to each course date. Course Leader The course is conduct ed in collaboration with Aurevia. Please note: Intertek operates under str ict standards of independence\, impartiality\, and integrity. Read more ab out how we work here: https://www.intertek.com/about/co​mpliance-governa nce/ Upcoming [...] END:VEVENT END:VCALENDAR