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UID:20261028T223325Z - 29235@odoo-54dc9f858c-c7xvh
DTSTART;TZID=Europe/Stockholm:20261007T090000
DTEND;TZID=Europe/Stockholm:20261007T160000
CREATED:20261028T223325Z
DESCRIPTION:<a href="https://package-1.intertek.test.cloudworkz.eu/event/ie
 c-62366-medical-device-usability-115/register">IEC 62366 - Medical Device 
 Usability</a>\nIt is important to consider usability during the developmen
 t of medical devices. Knowing how users handle the device is essential to 
 avoid usability-related safety issues and ensure proper functioning. The E
 uropean Medical Device Regulations\, MDR and IVDR\, require that products 
 are designed taking into account both the intended user and the intended e
 nvironment of use\, to reduce risks related to usability. The internationa
 l standard IEC 62366-1:2015 and AMD1:2020 describes the activities that sh
 ould be implemented in a process to meet the requirements of MDR/IVDR. Thi
 s one-day course focuses on the process described in the usability standar
 d. The course includes both theoretical sessions and practical exercises i
 n activities included in the standard. From the programHistory and regulat
 ory contextReview of the main definitions of the standardThe process - ste
 p by stepIn-depth look at summative evaluationHow do we meet the standard 
 for legacy products? Target group The course is primarily intended for tho
 se who work with the development of medical devices\, e.g. product owners\
 , product developers\, UX designers\, testers\, risk managers\, QA/RA\, bu
 t it is also aimed at product development managers\, marketing staff and u
 sers. Learning objectives After the course\, you will have a good understa
 nding of what is required from a regulatory perspective\, to establish a 
 “Usability Engineering File” for a medical device. After completing th
 e course\, a course certificate is issued to successful participants. Prio
 r knowledge The course is adapted for participants who have basic knowledg
 e of medical device development and medical device legislation. Course lan
 guage English Course leaders The training is conducted in collaboration wi
 th Aurevia. Please note: Intertek operates under strict standards of indep
 endence\, impartiality\, and integrity. Read more about how we work here: 
 [...]
DTSTAMP:20261028T223325Z
SUMMARY:IEC 62366 - Medical Device Usability
X-ALT-DESC;FMTTYPE=text/html:<a href="https://package-1.intertek.test.cloud
 workz.eu/event/iec-62366-medical-device-usability-115/register">IEC 62366 
 - Medical Device Usability</a>\nIt is important to consider usability duri
 ng the development of medical devices. Knowing how users handle the device
  is essential to avoid usability-related safety issues and ensure proper f
 unctioning. The European Medical Device Regulations\, MDR and IVDR\, requi
 re that products are designed taking into account both the intended user a
 nd the intended environment of use\, to reduce risks related to usability.
  The international standard IEC 62366-1:2015 and AMD1:2020 describes the a
 ctivities that should be implemented in a process to meet the requirements
  of MDR/IVDR. This one-day course focuses on the process described in the 
 usability standard. The course includes both theoretical sessions and prac
 tical exercises in activities included in the standard. From the programHi
 story and regulatory contextReview of the main definitions of the standard
 The process - step by stepIn-depth look at summative evaluationHow do we m
 eet the standard for legacy products? Target group The course is primarily
  intended for those who work with the development of medical devices\, e.g
 . product owners\, product developers\, UX designers\, testers\, risk mana
 gers\, QA/RA\, but it is also aimed at product development managers\, mark
 eting staff and users. Learning objectives After the course\, you will hav
 e a good understanding of what is required from a regulatory perspective\,
  to establish a “Usability Engineering File” for a medical device. Aft
 er completing the course\, a course certificate is issued to successful pa
 rticipants. Prior knowledge The course is adapted for participants who hav
 e basic knowledge of medical device development and medical device legisla
 tion. Course language English Course leaders The training is conducted in 
 collaboration with Aurevia. Please note: Intertek operates under strict st
 andards of independence\, impartiality\, and integrity. Read more about ho
 w we work here: [...]
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