Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme

Medical Device Design Control


Design Control is a substantial element of Quality System Regulation FDA 21 CFR Part 820 and ISO 13485 standards for medical device industries. Manufacturers must establish a robust design control processes to ensure develop a safe and effective finished product thus complies to regulatory requirements. This interactive course engages the participants with in-depth discussion of industry best practices to learn how industry leaders address design control challenges.



  1. Regulatory/QMS Compliance

1.1. QSR-21 CFR Part 820/EU MDR 2017/745                                                              

1.2. ISO 13485:2016, GHTF.SG3.N99-9               


  1. Introduction to Design Control

2.1. What is Medical Device Design Control Process                                                

2.2.  Application of Design Control-Waterfall Design Process                                                         

  1. Medical Device Classification

3.1. European Medical Device Classification                                                 

3.2. US FDA Device Classification                


  1. Implementing Design Control

4.1 Design & Development planning [21 CFR 820.30 (b)]

4.2 Design Inputs [21 CFR 820.30 (c)]

4.3 Design Outputs [21 CFR 820.30 (d)]

4.4 Design Reviews [21 CFR 820.30 (e)]

4.5 Design Verification [21 CFR 820.30 (f)]

4.6 Design Validation [21 CFR 820.30 (g)]

4.7 Design Transfer [21 CFR 820.30 (h)]

4.8 Design Changes [21 CFR 820.30 (i)

4.9 Design History file [21 CFR 820.30 (j)]



  1. Principles of Risk Management for Medical Device Design

5.1 Integration of risk management into the design and development lifecycle

5.2 Integration of risk assessment/risk management/ per ISO 14971:2019


  1. Design Control and Usability Engineering

6.1 Application of usability engineering in medical device design


  1. Design Control – Quality System Inspection Technique

7.1 QSIT inspection techniques for Design control


  1. Design Control Case Studies

8.1 Design control scenarios



  • Regulatory Personnel
  • Quality Engineers
  • Quality System Auditors
  • Management representatives
  • R & D staff
  • Risk Management Team members


Basic knowledge of medical devices and quality systems would be beneficial

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