Medical Device Management Systems

Medical Device Single Audit Program Awareness Training Course

A single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions

A single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions

ABOUT The COURSE

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.  Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. 

WHAT WILL YOU LEARN FROM THE COURSE?

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.  The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” 

TOPICS TO BE COVERED IN THE COURSE INCLUDE:

  • Introduction to MDSAP, management and measurement
  • Analysis and improvement
  • Design and development and production
  • Service controls, purchasing
  • Device marketing authorization and facility registration
  • Medical device adverse events and advisory notices
  • Country specific requirements -  USA, Brazil, Australia, Canada and Japan

WHAT IS THE COURSE METHODOLOGY?

There is a balance between knowledge-based presentation, discussions, exercises and case studies.

Exam details:
Participants will be assessed through an examination at the end of the course. Minimum passing % criteria: 70%.

Certification details:
Participants who score 70% and above in the examination will be issued a TÜV SÜD Thailand’s course completion certificate.

Prerequisites: None

Venue:      TÜV SÜD (Thailand) Limited, Pathum Thani

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Fee (pre-paid):

  • THB 8,000 for regular attendee
  • THB 7,600 for ISO 13485 Certification Customer of TÜV SÜD Thailand

*Prices above are exclusive of 7% VAT.


ABOUT THE SPEAKER

Paradee_Dolsook_Senior_Auditor_Medical_Health_ServiceKhun Parawee Dolsook, Senior Auditor Medical Health Service - Khun Parawee Dolsook currently contribute and leads the Medical Health Service Division, in TÜV SÜD Thailand, He is responsible for contribution of division strategic management and growth of TÜV SÜD’s market share for Medical Health Services. He is a recognized Lead Auditor for various schemes, including ISO 9001, ISO 13485, MDD, MDR, MDSAP.

He has a keen sense of business acumen and well-honed leadership skills, with than a decade of industry experience relating to manufacturing, research & development and under his belt. Khun Parawee started his career with Molnlycke Health Care (Thailand) Ltd., where he was responsible for quality assurance leader of medical device products being manufactured by the company, his role was to ensure that the product conformed to the desired requirement and quality attributes, he has a great career path during the work experience in company in promotion to work globally in a Research and Development Department in a role of Assistant Product Care Manager to contribute the new medical device implementation project launch to the market. Khun Parawee Dolsook holds a Masters in Business Administration, Major Marketing Management (MBA) , and Bachelor’s degree in Science – Major in Public Health in Occupational and Safety (B.Sc.), Major 
Petrochemical and Polymeric materials (B.Sc.). 

Khun Parawee Dolsook holds a Master in Business Administration, Marketing Management from Ramkhamhaeng University, and a Bachelor’s 
degree of Industrial Technology Science in Major of Petrochemical and Polymeric Material from Silapakorn University and a Bachelor’s degree 
of Science Program in Occupational Health and Safety from Sukhothai Thammathirat University.

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