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BEGIN:VEVENT
UID:20260831T074405Z - 36264@odoo-57766ccd69-mgjlj
DTSTART;TZID=Europe/Stockholm:20261007T090000
DTEND;TZID=Europe/Stockholm:20261007T160000
CREATED:20260831T074405Z
DESCRIPTION:<a href="https://ido.intertek.com/event/iec-62366-medical-devic
 e-usability-115/register">IEC 62366 - Medical Device Usability</a>\nIt is 
 important to consider usability during the development of medical devices.
  Knowing how users handle the device is essential to avoid usability-relat
 ed safety issues and ensure proper functioning. The European Medical Devic
 e Regulations\, MDR and IVDR\, require that products are designed taking i
 nto account both the intended user and the intended environment of use\, t
 o reduce risks related to usability. The international standard IEC 62366-
 1:2015 and AMD1:2020 describes the activities that should be implemented i
 n a process to meet the requirements of MDR/IVDR. This one-day course focu
 ses on the process described in the usability standard. The course include
 s both theoretical sessions and practical exercises in activities included
  in the standard. From the programHistory and regulatory contextReview of 
 the main definitions of the standardThe process - step by stepIn-depth loo
 k at summative evaluationHow do we meet 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 managers\, QA/RA\, but it is also aimed at
  product development managers\, marketing staff and users. Learning object
 ives After the course\, you will have a good understanding of what is requ
 ired from a regulatory perspective\, to establish a “Usability Engineeri
 ng File” for a medical device. After completing the course\, a course ce
 rtificate is issued to successful participants. Prior knowledge The course
  is adapted for participants who have basic knowledge of medical device de
 velopment and medical device legislation. Course language English Course l
 eaders The training is conducted in collaboration with Aurevia. Please not
 e: Intertek operates under strict standards of independence\, impartiality
 \, and integrity. Read more about how we work here: [...]
DTSTAMP:20260831T074405Z
SUMMARY:IEC 62366 - Medical Device Usability
X-ALT-DESC;FMTTYPE=text/html:<a href="https://ido.intertek.com/event/iec-62
 366-medical-device-usability-115/register">IEC 62366 - Medical Device Usab
 ility</a>\nIt is important to consider usability during the development of
  medical devices. Knowing how users handle the device is essential to avoi
 d usability-related safety issues and ensure proper functioning. The Europ
 ean Medical Device Regulations\, MDR and IVDR\, require that products are 
 designed taking into account both the intended user and the intended envir
 onment of use\, to reduce risks related to usability. The international st
 andard IEC 62366-1:2015 and AMD1:2020 describes the activities that should
  be implemented in a process to meet the requirements of MDR/IVDR. This on
 e-day course focuses on the process described in the usability standard. T
 he course includes both theoretical sessions and practical exercises in ac
 tivities included in the standard. From the programHistory and regulatory 
 contextReview of the main definitions of the standardThe process - step by
  stepIn-depth look at summative evaluationHow do we meet the standard for 
 legacy products? Target group The course is primarily intended for those w
 ho work with the development of medical devices\, e.g. product owners\, pr
 oduct developers\, UX designers\, testers\, risk managers\, QA/RA\, but it
  is also aimed at product development managers\, marketing staff and users
 . Learning objectives After the course\, you will have a good understandin
 g of what is required from a regulatory perspective\, to establish a “Us
 ability Engineering File” for a medical device. After completing the cou
 rse\, a course certificate is issued to successful participants. Prior kno
 wledge The course is adapted for participants who have basic knowledge of 
 medical device development and medical device legislation. Course language
  English Course 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: [...]
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