BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T131335Z
UID:7c8886d4-b6a1-4b44-876f-ce1e39773b22
DTSTART:20210222T080000
DTEND:20210223T080000
CLASS:PRIVATE
DESCRIPTION:Description
\n
\nThe new Medical Device Regulations (
MDR) were published in the Official Journal of the European Union on May 5
\, 2021. From that date\, manufacturers\, suppliers\, Notified Bodies\, an
d national competent authorities have a transition period of three years t
o comply with the new set of rules. Given the large scale of changes\, the
re is great pressure on all actors to analyze the MDR\, conduct impact ass
essments\, and implement compliant processes. After May 2020\, non-complia
nce threatens CE-mark certification\, access to the European market\, or\,
in the case of Notified Bodies\, re-designation.
\n
\n
\nA
reas Covered
\n
\n&bull\; \;  \;  \;Understand the M
edical Device Regulations approach in Europe
\n&bull\; \;  \;
 \;Understand the structure and purpose of the Medical Device Directi
ves \;
\n&bull\; \;  \;  \;Explain the use of Essenti
al requirements\, including the use of (harmonized) Standards
\n&bull
\; \;  \;  \;Understand the key changes upcoming in the new EU
MDR \;
\n&bull\; \;  \;  \;Understand the essence of
early start in the transition \;
\n&bull\; \;  \;  \
;Understand how to prepare a transition plan
\n&bull\; \;  \;
 \;Apply the Classification Criteria and Implementation rules
\n
&bull\; \;  \;  \;Identify the conformity assessment routes&nb
sp\;
\n&bull\; \;  \;  \;Identify Technical Documentation
requirements \;
\n
\n
\nWho will Benefit
\n
\nThis seminar is designed for new regulatory professionals and others in
related departments interested in understanding the basics of EU regulatio
n of medical devices and the impact on medical device companies. Participa
nts and attendees will be provided with a stimulating and practical workin
g environment. \;
\n \;  \;  \;  \;&bull\; Senior
Management \;
\n \;  \;  \;  \;&bull\; Regulator
y Affairs Managers and Quality Managers
\n \;  \;  \; &nb
sp\;&bull\; Design\, Development\, Manufacturing and Marketing Managers
\n \;  \;  \;  \;&bull\; Auditors
\n \;  \
;  \;  \;&bull\; Compliance/Regulatory affairs professionals
\n \;  \;  \;  \;&bull\; QA/QC professionals
\n \
;  \;  \;  \;&bull\; Manufacturing managers\, supervisors 
\;
\n \;  \;  \;  \;&bull\; Project Managers
\n<
br />\n
\nLearning Objectives
\n
\n&bull\; \;  \;Cl
ass I\, II and III/In Vitro Diagnostic medical device manufacturers
\
n&bull\; \;  \;Contract medical device manufacturers
\n&bull\
; \;  \;Contract sterilizers
\n&bull\; \;  \;Repackag
ers\, relabelers\, specification developers\, reprocessors of single-use d
evices
\n&bull\; \;  \;Manufacturers of accessories and compo
nents sold directly to the end user \;
\n&bull\; \;  \;U.
S. manufacturers of "\;export only"\; devices
\n&bull\; \
;  \;Distributors \;
SUMMARY:2 Days Workshop: Preparing For The New EU Medical Device Regulation
s (MDR)
BEGIN:VALARM
ACTION:DISPLAY
TRIGGER:-PT1H
SUMMARY:2 Days Workshop: Preparing For The New EU Medical Device Regulation
s (MDR)
END:VALARM
END:VEVENT
END:VCALENDAR