SS ISO 13485:2016 (2021)
Medical devices — Quality management systems — Requirements for regulatory purposes
OVERVIEW
This Singapore Standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations.
COMMENTS
The Handbook ISO 13485:2016 - Medical devices - A practical guide is available at this link : https://www.singaporestandardseshop.sg/product/product.aspx?id=7fb06742-0ca1-49f9-92ca-6d9b152b130d
PRODUCT DETAILS
| Status | Confirmed |
|---|---|
| Edition | 2016 (2021) |
| No. of Pages | 51 |
| ICS Classification | 03.100.70 Management systems 11.040.01 Medical equipment in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 13485 : 2016 IDT |