Medical Device Design Control

Course Title: Medical Device Design Control

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3052


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 EN ISO 14971:2012


  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.




Mr. Gobu Devarajan possesses Master Degree in Electrical and Electronic Engineering and Certified Manager of Quality/Organizational Excellence (CMQ/OE, Certified Quality Auditor (CQA) from American Society of Quality (ASQ). Certified Six Sigma Green Belt.


He has more than twenty five years of working experience with extensive knowledge in the field of Quality Engineering, Statistical Analysis and Quality System Requirements. He possesses excellent communication and presentation skills. He is capable of designing, conducting training programs and perform gap analysis according to QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 16949 and ISO 14971. MDD 93/42/EEC, CMDCAS and JPAL