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BEGIN:VEVENT
UID:20260808T053954Z - 2037@odoo-6c455687b8-9vjd8
DTSTART;TZID=Europe/Stockholm:20261013T090000
DTEND;TZID=Europe/Stockholm:20261013T160000
CREATED:20260808T053954Z
DESCRIPTION:<a href="https://18-0-staging.intertek.test.cloudworkz.eu/event
 /ce-marking-of-medical-devices-mdr-ivdr-deep-dive-day-2-64/register">CE Ma
 rking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2</a>\nAs a manufact
 urer\, importer\, or distributor of medical devices on the EU market\, you
  operate in one of the world's most regulated landscapes. CE marking is no
 t just a label – it is proof that your product meets strict requirements
  for safety\, performance\, documentation\, and quality management. This t
 raining provides a clear and practical walkthrough of what it takes to CE 
 mark your product and bring it to market. This is part 2 (day 2) of the co
 urse CE Marking of Medical Devices (MDR/IVDR) the big picutere - day 1. Yo
 u must have attended day 1 to be able to attend day 2. The requirements ha
 ve tightened significantly under MDR and IVDR: UDI labelling\, cybersecuri
 ty\, enhanced clinical evaluation\, and more extensive technical documenta
 tion are just a few examples. We cut through the complexity – and help y
 ou see the full picture. The fundamental purpose of the regulations is to 
 protect patients and users. But the consequences of non-compliance are als
 o very real: market bans\, product recalls\, and liability claims. This co
 urse focuses on the path to CE marking. We explain\, discuss\, and practic
 e key concepts – and walk through how technical documentation should be 
 structured and what role regulatory authorities and Notified Bodies play. 
 Programme Overview Day 2 – Deep DiveTechnical documentation: structure\,
  content\, and common deficienciesQuality management systems under MDR/IVD
 R and ISO 13485Labelling and instructions for useIntroduction to key proce
 ss standards:ISO 14971 (risk management)IEC 62366-1 (usability)IEC 62304 (
 software)Cybersecurity: IEC 81001-5-1 and MDCG 2019-16Artificial intellige
 nce and medical devices\, including the AI ActPost-Market Surveillance and
  VigilanceNotified Bodies and the certification process (with a guest repr
 esentative from Intertek) The course combines lectures with multiple hands
 -on exercises and practical activities\, including [...]
DTSTAMP:20260808T053954Z
SUMMARY:CE Marking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2
X-ALT-DESC;FMTTYPE=text/html:<a href="https://18-0-staging.intertek.test.cl
 oudworkz.eu/event/ce-marking-of-medical-devices-mdr-ivdr-deep-dive-day-2-6
 4/register">CE Marking of Medical Devices (MDR/IVDR) - Deep Dive - Day 2</
 a>\nAs a manufacturer\, importer\, or distributor of medical devices on th
 e EU market\, you operate in one of the world's most regulated landscapes.
  CE marking is not just a label – it is proof that your product meets st
 rict requirements for safety\, performance\, documentation\, and quality m
 anagement. This training provides a clear and practical walkthrough of wha
 t it takes to CE mark your product and bring it to market. This is part 2 
 (day 2) of the course CE Marking of Medical Devices (MDR/IVDR) the big pic
 utere - day 1. You must have attended day 1 to be able to attend day 2. Th
 e requirements have tightened significantly under MDR and IVDR: UDI labell
 ing\, cybersecurity\, enhanced clinical evaluation\, and more extensive te
 chnical documentation are just a few examples. We cut through the complexi
 ty – and help you see the full picture. The fundamental purpose of the r
 egulations is to protect patients and users. But the consequences of non-c
 ompliance are also very real: market bans\, product recalls\, and liabilit
 y claims. This course focuses on the path to CE marking. We explain\, disc
 uss\, and practice key concepts – and walk through how technical documen
 tation should be structured and what role regulatory authorities and Notif
 ied Bodies play. Programme Overview Day 2 – Deep DiveTechnical documenta
 tion: structure\, content\, and common deficienciesQuality management syst
 ems under MDR/IVDR and ISO 13485Labelling and instructions for useIntroduc
 tion to key process standards:ISO 14971 (risk management)IEC 62366-1 (usab
 ility)IEC 62304 (software)Cybersecurity: IEC 81001-5-1 and MDCG 2019-16Art
 ificial intelligence and medical devices\, including the AI ActPost-Market
  Surveillance and VigilanceNotified Bodies and the certification process (
 with a guest representative from Intertek) The course combines lectures wi
 th multiple hands-on exercises and practical activities\, including [...]
END:VEVENT
END:VCALENDAR