MMD-113    An Overview of Medical Device GMP requirements for South Korea

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This course is designed to provide participants with the knowledge on medical device regulations pertaining to Good Manufacturing Practices for South Korea. Internal and external auditors and personnel responsible for quality systems for medical device manufacturers will benefit from this course.  Participants will gain an overview of the requirements of the South Korean regulatory process.

Participants will be led by an experienced trainer whom, in addition to being a medical device quality systems auditor and product approval reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will engage in exercises and discussion points, including considerations in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance. 

This course is designed for :
 

• Regulatory and quality staff responsible for preparing or hosting MDSAP audits and/or KFDA / 3rd Party Audits
• Design personnel
• Internal and external auditors
• Organizations wishing to place their medical devices in South Korean markets

• Section 1: Overview of the medical device legislature
  
• Section 2: Overview of the Regulatory Framework
  
• Section 3: Introduction to Risk Classification
  
• Section 4: Introduction to the Essential Requirements for Medical Devices
  
• Section 5: Overview of the Role of Standards
  
• Section 6: Overview of Labelling Requirements
  
• Section 7: Overview of Post Market Activities
  
• Section 8: Overview of Risk Management for Medical Devices
  
• Section 9: Overview of Technical Documentation
  

This course is designed for :

• Regulatory and quality staff responsible for preparing or hosting MDSAP audits and/or KFDA / 3rd Party Audits
• Design personnel
• Internal and external auditors
• Organizations wishing to place their medical devices in South Korean markets

This is a ​1-day programme.
​
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.