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UID:20260831T074640Z - 16321@odoo-57766ccd69-mgjlj
DTSTART;TZID=Europe/Stockholm:20260929T093000
DTEND;TZID=Europe/Stockholm:20260930T160000
CREATED:20260831T074640Z
DESCRIPTION:Quality Manage
ment System according to EN ISO 13485:2016 - in practice\nEstablishing
an effective Quality Management System (QMS) is crucial for most organiza
tions in the medical device supply chain. For some 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 IVDR 2017/746) This cour
se explains the requirements of the standard in a clear and coherent way a
nd exemplifies its interpretation and application in different kinds of or
ganizations. The course provides a basic understanding of the requirements
and how to design\, deploy\, and maintain a working QMS. From the program
ISO 13485 – History\, purpose\, scope and future QMS – The big picture
\, CE-markingRelationship with ISO 9001 and MDR/IVDRRelationship with othe
r Management System Standards and legal requirementsDetails of requirement
s and interpretation of EN ISO 13485:2016Challenges and best practices Tar
get group This course is intended for personnel working with quality assur
ance\, product development\, production and management\, including interna
l auditors\, process owners\, and regulatory staff at companies within the
medical device supply chain. Educational goals After the course\, partici
pants will have a basic understanding of the standard and how to establish
and maintain a QMS based on it. Prior knowledge A basic knowledge of mana
gement systems and experience from the medical device domain is recommende
d. Course presentation and language Course material is in English. The cou
rse is held in Swedish or English\, as specified next to each course date.
Course Leader The course is conducted in collaboration with Aurevia. Plea
se note: Intertek operates under strict standards of independence\, impart
iality\, and integrity. Read more about how we work here: https://www.inte
rtek.com/about/compliance-governance/ Upcoming [...]
DTSTAMP:20260831T074640Z
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 13485:2016 - in practice<
/a>\nEstablishing an effective Quality Management System (QMS) is crucial
for most organizations in the medical device supply chain. For some mar
kets\, it is even a must. The harmonized EN ISO 13485:2016 standard offers
a structured way to successfully establish such a QMS\, fulfilling applic
able sections of both Medical Device Regulations (MDR 2017/745 and IVDR 20
17/746) This course explains the requirements of the standard in a clear a
nd coherent way and exemplifies its interpretation and application in diff
erent 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/IVDRRel
ationship with other Management System Standards and legal requirementsDet
ails of requirements and interpretation of EN ISO 13485:2016Challenges and
best practices Target group This course is intended for personnel working
with quality assurance\, product development\, production and management\
, including internal auditors\, process owners\, and regulatory staff at c
ompanies within the medical device supply chain. Educational goals After t
he course\, participants will have a basic understanding of the standard a
nd how to establish and maintain a QMS based on it. Prior knowledge A basi
c knowledge of management systems and experience from the medical device d
omain is recommended. Course presentation and language Course material is
in English. The course is held in Swedish or English\, as specified next t
o each course date. Course Leader The course is conducted in collaboration
with Aurevia. Please note: Intertek operates under strict standards of in
dependence\, impartiality\, and integrity. Read more about how we work her
e: https://www.intertek.com/about/compliance-governance/ Upcoming [...]
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