Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme
Medical Device Design Control
INTRODUCTION
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.
COURSE OUTLINE
- Regulatory/QMS Compliance
1.1. QSR-21 CFR Part 820/EU MDR 2017/745
1.2. ISO 13485:2016, GHTF.SG3.N99-9
- Introduction to Design Control
2.1. What is Medical Device Design Control Process
2.2. Application of Design Control-Waterfall Design Process
- Medical Device Classification
3.1. European Medical Device Classification
3.2. US FDA Device Classification
- 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)]
- 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
- Design Control and Usability Engineering
6.1 Application of usability engineering in medical device design
- Design Control – Quality System Inspection Technique
7.1 QSIT inspection techniques for Design control
- Design Control Case Studies
8.1 Design control scenarios
TARGET AUDIENCE
- Regulatory Personnel
- Quality Engineers
- Quality System Auditors
- Management representatives
- R & D staff
- Risk Management Team members
PRE-REQUISITES
Basic knowledge of medical devices and quality systems would be beneficial