Dirigeants et représentants réglementaires de Optolab
KENNELLY Valerie
1.Overall design of the product, validation, verification and organising independent professionals to prepare clinical validation certification.
2. Ensuring the conformity of the device QMS in accordance with ISO13485 prior to release.
3. Ensuring that the technical documentation and EU declaration of conformity are drawn up and kept up-to-date.
4. Ensuring that the post-market surveillance obligations are complied with.