SEIMETZ Erik
Main PRRC for:
Art. 15 (EU)2017/745
Contact to EUDAMED, Health Authorities and Notfied Bodies
Masqué
SCHICHTEL Dr. Julian
Deputy PRRC for:
Art. 15(EU) 2017/745
Contact to EUDAMED, Health Authorities and Notfied Bodies
Main PRRC for:
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes –liquid dosage forms)
Deputy PRRC for:
Article 15, (3)e), Annex I-IV, Annex XV, Chap.II, 4.1
Check of conformity of manufactured products with QMS and release (internal processes - test medication for clinical trials)
Masqué
HÜTTER Sarah
Main PRRC for:
Article 15, (3)e), Annex I-IV, Annex XV, Chap. II, 4.1
Check of conformity of manufactured products with QMS and release (internal processes -test medication for clinical trials)
Deputy PRRC for:
Article 15, (3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes – liquid dosage forms)
Masqué
TASCEDDA Dr. Patricia
Main PRRC for:
Article15, (3)a), Annex I - IV
Check of conformity of manufactured products with QMS and release (internal processes –semi-solid dosage forms)
Deputy PRRC for:
Article 15,(3) a), Annex I - IV
Check of conformity of manufactured products with QMS and release (external processes –quality of externally manufactured products)
Masqué
WIEGAND Dr. Christian
Main PRRC for:
Article 15, (3)a), Annex I - IV
Check of conformity of manufactured products with QMS and release (external processes –quality of externally manufactured products)
Deputy PPRC for:
Article15,(3) a), Annex I - IV Check of conformity of manufactured products with QMS and release (internal processes –semi-solid dosage forms)
Masqué
STEINMETZ Charlotte
Main PRRC for:
Article 15,(3)c), Art. 80, Art. 83 ff.
Post Market Surveillance
Main PRRC for:
Article 15, (3)d), Art. 80, Art. 87 – 91
Vigilance Reporting
Masqué
GROSS Dorothea
Deputy PRRC for:
Article 15,(3)c), Art. 80, Art. 83 ff.
Post Market Surveillance
Deputy PRRC for:
Article 15, (3)d), Art. 80, Art. 87 – 91
Vigilance Reporting
Masqué
STEIN Michaela
Main PRRC for:
Article 15,(3)b), Annex I - IV
Check of conformity of Technical Documentation with the requirements of Annexes II and III of MDR
Masqué
RÖCKER Katja
Deputy PRRC for:
Article 15,(3)b), Annex I - IV
Check of conformity of Technical Documentation with the requirements of Annexes II and III of MDR
Masqué