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UID:20260831T094539Z - 63599@odoo-57766ccd69-mgjlj
DTSTART;TZID=Europe/Stockholm:20261125T090000
DTEND;TZID=Europe/Stockholm:20261126T160000
CREATED:20260831T094539Z
DESCRIPTION:Medical device software p
rocess design based on IEC 62304 \nThis course focuses on how to desig
n a process for the development and maintenance of medical device software
according to the IEC 62304 standard and the regulatory requirements that
apply to medical device software. TopicsCurrent software practicesDesignin
g high quality software in a regulated environmentStandards for regulatory
complianceImplementation examples for achieving compliancePractical appli
cations of the requirements of the 62304 standardSome possible future chan
ges within the medical device software field Target group This course is t
argeted towards professionals working with the development of medical devi
ces containing software or software as a medical device (SaMD)\, with risk
assessment of software-based products\, quality assurance\, process impro
vements\, with the purchasing of software development from subcontractors\
, or purchasing software components. Educational goals After the course\,
participants will have an understanding of how to employ design processes
for medical device development based on the 62304 standard\, in order to a
chieve regulatory compliance and how to design high quality software in a
regulated environment. Recommended prior knowledge A basic understanding o
f the medical device regulations and some product and software development
experience is recommended. Course presentations Course material will
be in English\, verbal presentation in English. Course leaders The trainin
g is conducted in collaboration with Aurevia. Please note: Intertek operat
es under strict standards of independence\, impartiality\, and integrity.
Read more about how we work here: https://www.intertek.com/about/compli
ance-governance/ Upcoming courses See all Your Dynamic Snippet will be dis
played here... This message is displayed because you did not provide both
a filter and a template to use.
DTSTAMP:20260831T094539Z
LOCATION:Intertek Semko AB\, Torshamnsgatan 43\, Kista 16440\, Sweden
SUMMARY:Medical device software process design based on IEC 62304
X-ALT-DESC;FMTTYPE=text/html:Medical
device software process design based on IEC 62304 \nThis course focuse
s on how to design a process for the development and maintenance of medica
l device software according to the IEC 62304 standard and the regulatory r
equirements that apply to medical device software. TopicsCurrent software
practicesDesigning high quality software in a regulated environmentStandar
ds for regulatory complianceImplementation examples for achieving complian
cePractical applications of the requirements of the 62304 standardSome pos
sible future changes within the medical device software field Target group
This course is targeted towards professionals working with the developmen
t of medical devices containing software or software as a medical device (
SaMD)\, with risk assessment of software-based products\, quality assuranc
e\, process improvements\, with the purchasing of software development fro
m subcontractors\, or purchasing software components. Educational goals Af
ter the course\, participants will have an understanding of how to employ
design processes for medical device development based on the 62304 standar
d\, in order to achieve regulatory compliance and how to design high quali
ty software in a regulated environment. Recommended prior knowledge A basi
c understanding of the medical device regulations and some product and sof
tware development experience is recommended. Course presentations Cour
se material will be in English\, verbal presentation in English. Course le
aders The training is conducted in collaboration with Aurevia. Please note
: Intertek operates under strict standards of independence\, impartiality\
, and integrity. Read more about how we work here: https://www.intertek.co
m/about/compliance-governance/ Upcoming courses See all Your Dynamic Sn
ippet will be displayed here... This message is displayed because you did
not provide both a filter and a template to use.
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