Title: Director, Global Regulatory Affairs. Responsible for ensuring that:
1. The conformity of medical devices are checked in accordance with the QMS under which the medical devices are manufactured, before a device is released;
2. The technical documentation and the EU declaration of conformity (DoC) are drawn up and kept up to date;
3. The Post-Market Surveillance (PMS) are complied in accordance with EU MDR;
4. The reporting obligations referred to in Articles 87 to 91 are fulfilled.
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SANDERS Kayla
Title: Manager, Global Regulatory Affairs. Responsible for ensuring that:
1. The conformity of medical devices are checked in accordance with the QMS under which the medical devices are manufactured, before a device is released;
2. The technical documentation and the EU declaration of conformity (DoC) are drawn up and kept up to date;
3. The Post-Market Surveillance (PMS) are complied in accordance with EU MDR;
4. The reporting obligations referred to in Articles 87 to 91 are fulfilled.
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WOJCICKI John
Title: Sr. Manager Quality. Responsible for ensuring that:
1. The conformity of medical devices are checked in accordance with the QMS under which the medical devices are manufactured, before a device is released;
2. The technical documentation and the EU declaration of conformity (DoC) are drawn up and kept up to date;
3. The Post-Market Surveillance (PMS) are complied in accordance with EU MDR;
4. The reporting obligations referred to in Articles 87 to 91 are fulfilled.
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Cartography of Thermo Fisher Scientific (Asheville) LLC