Techcyte, Inc.

Pre-Market Compliance: Ensure device conformity, maintain technical documentation (Article 10(4)), and a valid EU Declaration of Conformity (Article 17). Post-Market Surveillance: Oversee PMS (Article 78), including PMPF. Vigilance & Reporting: Ensure compliance with Articles 87–91 for incidents, FSCA, trend reporting, and corrective actions. Collaboration: Work cross-functionally; document PRRC roles (Article 15(4)). PRRC Qualifications: Degree +1 year or 4 years experience in IVD regulatory.