Responsible for ensuring:
- Technical documentation and DoC are drawn and up-to-date
- Post market surveillance obligation are complied
- Reporting obligations are fulfilled as required
- Appropriate statement is available in case of intervention clinical performance studies or other studies
- Device conformity is properly check prior to release
Masqué
LEE John
Responsible for ensuring:
- Device conformity is properly check prior to release
- Technical documentation and DoC are drawn and up-to-date
- Post market surveillance obligation are complied
- Reporting obligations are fulfilled as required
- Appropriate statement is available in case of intervention clinical performance studies or other studies