Table of Contents
How to fill up GSPR Updated: 19th July2020
How to fill up GSPR:
| GSPR | Description | Applicable? | Method applied | Standards and Solutions | Evidence |
| 7 | Devices shall be designed , manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer | Yes | Products is tested via transportation test (vibration and drop and variation of temperature as per indicated in the instructions provided by manufacturer) as per Design requirements. | EN ISO 13485: 2016 EN ISO 11607-1:2009 | Design Control SOP XXX located in QMS system. Test report XXX located in section XXX of Technical File XXX. |
| 11.5 | Devices labeled as sterile shall be processed, manufactured, packaged and, sterilized by the means of appropriate, validated methods | No, device is not meant to be provided as sterile product | Not applicable | Not applicable | Not applicable |
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