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UID:20260808T054140Z - 50444@odoo-6c455687b8-9vjd8
DTSTART;TZID=Europe/Stockholm:20261007T090000
DTEND;TZID=Europe/Stockholm:20261007T160000
CREATED:20260808T054140Z
DESCRIPTION:<a href="https://18-0-staging.intertek.test.cloudworkz.eu/event
 /iec-62366-medical-device-usability-42/register">IEC 62366 - Medical Devic
 e Usability</a>\nIt is important to consider usability during the developm
 ent of medical devices. Knowing how users handle the device is essential t
 o avoid usability-related safety issues and ensure proper functioning. The
  European Medical Device Regulations\, MDR and IVDR\, require that product
 s are designed taking into account both the intended user and the intended
  environment of use\, to reduce risks related to usability. The internatio
 nal standard IEC 62366-1:2015 and AMD1:2020 describes the activities that 
 should be implemented in a process to meet the requirements of MDR/IVDR. T
 his one-day course focuses on the process described in the usability stand
 ard. The course includes both theoretical sessions and practical exercises
  in activities included in the standard.From the programHistory and regula
 tory contextReview of the main definitions of the standardThe process - st
 ep by stepIn-depth look at summative evaluationHow do we meet the standard
  for legacy products? Target group The course is primarily intended for th
 ose who work with the development of medical devices\, e.g. product owners
 \, product developers\, UX designers\, testers\, risk managers\, QA/RA\, b
 ut is also aimed at product development managers\, marketing staff and use
 rs. Learning objectives After the course\, you will have a good understand
 ing of what is required from a regulatory perspective\, to establish a “
 Usability Engineering File” for a medical device. After completing the c
 ourse\, a course certificate is issued to successful participants.Prior kn
 owledge The course is adapted for participants who have basic knowledge of
  medical device development and medical device legislation. Course languag
 e EnglishCourse leaders The training is conducted in collaboration with Au
 revia. Please note: Intertek operates under strict standards of independen
 ce\, impartiality\, and integrity. Read more about how we work here: [...]
DTSTAMP:20260808T054140Z
SUMMARY:IEC 62366 - Medical Device Usability
X-ALT-DESC;FMTTYPE=text/html:<a href="https://18-0-staging.intertek.test.cl
 oudworkz.eu/event/iec-62366-medical-device-usability-42/register">IEC 6236
 6 - Medical Device Usability</a>\nIt is important to consider usability du
 ring the development of medical devices. Knowing how users handle the devi
 ce is essential to avoid usability-related safety issues and ensure proper
  functioning. The European Medical Device Regulations\, MDR and IVDR\, req
 uire that products are designed taking into account both the intended user
  and the intended environment of use\, to reduce risks related to usabilit
 y. The international standard IEC 62366-1:2015 and AMD1:2020 describes the
  activities that should be implemented in a process to meet the requiremen
 ts of MDR/IVDR. This one-day course focuses on the process described in th
 e usability standard. The course includes both theoretical sessions and pr
 actical exercises in activities included in the standard.From the programH
 istory and regulatory contextReview of the main definitions of the standar
 dThe process - step by stepIn-depth look at summative evaluationHow do we 
 meet the standard for legacy products? Target group The course is primaril
 y intended for those who work with the development of medical devices\, e.
 g. product owners\, product developers\, UX designers\, testers\, risk man
 agers\, QA/RA\, but is also aimed at product development managers\, market
 ing staff and users. Learning objectives After the course\, you will have 
 a good understanding of what is required from a regulatory perspective\, t
 o establish a “Usability Engineering File” for a medical device. After
  completing the course\, a course certificate is issued to successful part
 icipants.Prior knowledge The course is adapted for participants who have b
 asic knowledge of medical device development and medical device legislatio
 n. Course language EnglishCourse leaders The training is conducted in coll
 aboration with Aurevia. Please note: Intertek operates under strict standa
 rds of independence\, impartiality\, and integrity. Read more about how we
  work here: [...]
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