Job Description (JD)
| Nama Program | PENGURUSAN PENGELUARAN ALAT PERUBATAN [C210-001-5:2017] |
|---|---|
| Kod CU | C210-001-5:2017-C05 |
| Competency | Core |
| Tajuk CU | MEDICAL DEVICES PRODUCTION PRE & POST MARKET SURVEILLANCE |
| Penerangan CU | Medical Devices Production Pre & Post Market Surveillance describes the competency in controlling and monitoring the safety of a medical device before and after it has been released on the market. A competent person in this CU shall be able tomanage market analysis, develop Instruction For Use (IFU), manage product safety requirements and manage product re-evaluation. The outcome of this competency is to efficiently manage safety compliance of medical device in accordance with related regulatory bodies’ requirements. |
| Tempoh Latihan | 180 |
| Objektif Pembelajaran | The person who is competent in this CU shall be able to efficiently manage safety compliance of medical device in accordance with related regulatory bodies’ requirements. Upon completion of this competency units, trainees will be able to:- 1. Manage market analysis 2. Develop Instruction For Use (IFU) 3. Manage product safety requirements 4. Manage product re-evaluation |
| Pra-Syarat | 0 |