ISO 13485:2016, as an international standard for Quality Management System Requirements stipulated in the medical device industry, involves the design, development, production, installation and service of medical devices. Through the study of this course, students can understand the structure and requirements of ISO13485 Quality Management System. According to ISO 19011:2018 "Audit Management system Guide" to provide students with in-depth knowledge and skills in auditing. So that students have ISO13485 audit basic ability. Meet the requirements of ISO13485:2016 medical device quality management director auditor system director auditor.
The course meets the training requirement for Exemplar Global (TPECS) Auditor certification program for the below achievement.
The course meets the training requirements for Exemplar Global (TPECS) Provisional Auditor Certification for medical device.
Intertek Course advantage
Training Provider introduction
Mr. Steven Wang
More than 10 years of clinical medicine practice experience, clinical intervention and laboratory experience. Many years of multinational enterprise medical device quality and design experience. Independently led more than 50 European Union and American product launching projects. The founder of CFP theory. I have served in many EU announcement institutions (UK, Germany, Netherlands), in charge of clinical review of medical devices, microbial sterilization review, CE review and audit of high-risk products, and successively served as technical director, chief lecturer and certificate issuing review, with rich practical experience.
The lecturer adopts a unique practical interactive way. The class is humorous, close to reality and nature, and leads the students to think in a very simple way.
Who should attend
This course is certified by Exemplar Global under the TPECS scheme.Upon successful completion of this course and passing the examination, students will be granted Certificate of Attainment with the following Exemplar Global competency units
5 days (40 hours)
Course Time and Venues
|Date and Time
|Oct, 23-27, 2023
*The specific time may be adjusted according to the registration situation.
*The specific training venue will be informed before the start of the course according to the students' registration situation.
RMB 12,000 per person
Limited time discount, register as soon as possible
Please contact customer service representative for details.
Bank Account No. 10717034003
Intertek is a leading Total Quality Assurance provider to industries worldwide with professional, accurate, fast, passionate total quality assurance service, to win the market escort for customers.Our network of more than 1,000 laboratories and offices and over 44,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains.
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