Cobalt Contraception

Verifying the conformity of each device before release. Ensuring technical documentation and declarations of conformity are properly prepared and maintained. Ensuring post-market surveillance and vigilance obligations are fulfilled. Reviewing and validating incident reports, coordinating FSCA notifications, and communicating with competent authorities where required. Supporting trend reporting and periodic safety update reporting (PSUR), in accordance with Articles 83 to 92 of the MDR.

Verifying the conformity of each device before release. Ensuring technical documentation and declarations of conformity are properly prepared and maintained. Ensuring post-market surveillance and vigilance obligations are fulfilled. Reviewing and validating incident reports, coordinating FSCA notifications, and communicating with competent authorities where required. Supporting trend reporting and periodic safety update reporting (PSUR), in accordance with Articles 83 to 92 of the MDR.