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:20260808T054049Z - 9732@odoo-6c455687b8-9vjd8 DTSTART;TZID=Europe/Stockholm:20260929T093000 DTEND;TZID=Europe/Stockholm:20260930T160000 CREATED:20260808T054049Z DESCRIPTION:Quality Management System according to EN ISO 13485:2016 - in pra ctice\nEstablishing an effective Quality Management System (QMS) is cr ucial for most organization​s in the medical device supply chain. For so me markets\, it is even a must. The harmonized EN ISO 13485:2016 standard offers a structured way to successfully establish such a QMS\, fulfilling applicable sections of both Medical Device Regulations (MDR 2017/745 and I VDR 2017/746) This course explains the requirements of the standard in a c lear and coherent way and exemplifies its interpretation and application i n different kinds of organizations. The course provides a basic understand ing of the requirements and how to design\, deploy\, and maintain a workin g QMS. From the programISO 13485 – History\, purpose\, scope and future QMS – The big picture\, CE-markingRelationship with ISO 9001 and MDR/IVD RRelationship with other Management System Standards and legal requirement sDetails of requirements and interpretation of EN ISO 13485:2016Challenges and best practicesTarget group This course is intended for personnel work ing with quality assurance\, product development\, production and manageme nt\, including internal auditors\, process owners\, and regulatory staff a t companies within the medical device supply chain. Educational goals Afte r the course\, participants will have a basic understanding of the standar d and how to establish and maintain a QMS based on it. Prior knowledge A b asic knowledge of management systems and experience from the medical devic e domain is recommended. Course presentation and language Course material is in English. The course is held in Swedish or English\, as specified nex t to each course date. Course leaders Cilla Lundevall Wiberg\, Principal Q uality & Regulatory Consultant\, has 25+ years of experience working with quality assurance in various positions in several medical device organizat ions with different product types. The course is conducted in collaboratio n [...] DTSTAMP:20260808T054049Z 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 13 485:2016 - in practice\nEstablishing an effective Quality Management S ystem (QMS) is crucial for most organization​s in the medical device sup ply chain. For some markets\, it is even a must. The harmonized EN ISO 134 85:2016 standard offers a structured way to successfully establish such a QMS\, fulfilling applicable sections of both Medical Device Regulations (M DR 2017/745 and IVDR 2017/746) This course explains the requirements of th e standard in a clear and coherent way and exemplifies its interpretation and application in different kinds of organizations. The course provides a basic understanding of the requirements and how to design\, deploy\, and maintain a working QMS. From the programISO 13485 – History\, purpose\, scope and future QMS – The big picture\, CE-markingRelationship with ISO 9001 and MDR/IVDRRelationship with other Management System Standards and legal requirementsDetails of requirements and interpretation of EN ISO 134 85:2016Challenges and best practicesTarget group This course is intended f or personnel working with quality assurance\, product development\, produc tion and management\, including internal auditors\, process owners\, and r egulatory staff at companies within the medical device supply chain. Educa tional goals After the course\, participants will have a basic understandi ng of the standard and how to establish and maintain a QMS based on it. Pr ior knowledge A basic knowledge of management systems and experience from the 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 leaders Cilla Lundevall Wib erg\, Principal Quality & Regulatory Consultant\, has 25+ years of experie nce working with quality assurance in various positions in several medical device organizations with different product types. The course is conducte d in collaboration [...] END:VEVENT END:VCALENDAR