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UID:20260808T045632Z - 86441@odoo-6c455687b8-9vjd8
DTSTART;TZID=Europe/Stockholm:20260929T093000
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CREATED:20260808T045632Z
DESCRIPTION:Quality Management System according to EN ISO 13485:2016 - in pra
ctice\nEstablishing an effective Quality Management System (QMS) is cr
ucial for most organizations in the medical device supply chain. For so
me markets\, it is even a must. The harmonized EN ISO 13485:2016 standard
offers a structured way to successfully establish such a QMS\, fulfilling
applicable sections of both Medical Device Regulations (MDR 2017/745 and I
VDR 2017/746) This course explains the requirements of the standard in a c
lear and coherent way and exemplifies its interpretation and application i
n different kinds of organizations. The course provides a basic understand
ing of the requirements and how to design\, deploy\, and maintain a workin
g QMS. From the programISO 13485 – History\, purpose\, scope and future
QMS – The big picture\, CE-markingRelationship with ISO 9001 and MDR/IVD
RRelationship with other Management System Standards and legal requirement
sDetails of requirements and interpretation of EN ISO 13485:2016Challenges
and best practices Target group This course is intended for personnel wor
king with quality assurance\, product development\, production and managem
ent\, including internal auditors\, process owners\, and regulatory staff
at companies within the medical device supply chain. Educational goals Aft
er the course\, participants will have a basic understanding of the standa
rd and how to establish and maintain a QMS based on it. Prior knowledge A
basic knowledge of management systems and experience from the medical devi
ce domain is recommended. Course presentation and language Course material
is in English. The course is held in Swedish or English\, as specified ne
xt to each course date. Course Leader The course is conducted in collabora
tion with Aurevia. Please note: Intertek operates under strict standards o
f independence\, impartiality\, and integrity. Read more about how we work
here: https://www.intertek.com/about/compliance-governance/ Upcoming [
...]
DTSTAMP:20260808T045632Z
LOCATION:Intertek Semko AB\, Torshamnsgatan 43\, Kista 16440\, Sweden
SUMMARY:Quality Management System according to EN ISO 13485:2016 - in pract
ice
X-ALT-DESC;FMTTYPE=text/html:Quality Management System according to EN ISO 13
485:2016 - in practice\nEstablishing an effective Quality Management S
ystem (QMS) is crucial for most organizations in the medical device sup
ply chain. For some markets\, it is even a must. The harmonized EN ISO 134
85:2016 standard offers a structured way to successfully establish such a
QMS\, fulfilling applicable sections of both Medical Device Regulations (M
DR 2017/745 and IVDR 2017/746) This course explains the requirements of th
e standard in a clear and coherent way and exemplifies its interpretation
and application in different kinds of organizations. The course provides a
basic understanding of the requirements and how to design\, deploy\, and
maintain a working QMS. From the programISO 13485 – History\, purpose\,
scope and future QMS – The big picture\, CE-markingRelationship with ISO
9001 and MDR/IVDRRelationship with other Management System Standards and
legal requirementsDetails of requirements and interpretation of EN ISO 134
85:2016Challenges and best practices Target group This course is intended
for personnel working with quality assurance\, product development\, produ
ction and management\, including internal auditors\, process owners\, and
regulatory staff at companies within the medical device supply chain. Educ
ational goals After the course\, participants will have a basic understand
ing of the standard and how to establish and maintain a QMS based on it. P
rior knowledge A basic knowledge of management systems and experience from
the medical device domain is recommended. Course presentation and languag
e Course material is in English. The course is held in Swedish or English\
, as specified next to each course date. Course Leader The course is condu
cted in collaboration with Aurevia. Please note: Intertek operates under s
trict standards of independence\, impartiality\, and integrity. Read more
about how we work here: https://www.intertek.com/about/compliance-gover
nance/ Upcoming [...]
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