Officers and regulatory representatives of AIDD Sligo
HAREN Noel
PRRC (Regulatory): Ensures that technical documentation and Declarations of Conformity are drawn up and kept up-to-date
Approves Declaration of Conformity (DoC). Ensures CE-mark on product labeling complies to the IVD-R. Participates in Site Management Reviews. Ensures reporting requirements are met.
Acts as the primary point of contact for Regulatory-related communication with the Notified Bodies or Competent Authorities.
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MCDONAGH Thomas
PRRC (Regulatory): Ensures that technical documentation and Declarations of Conformity are drawn up and kept up-to-date
Approves Declaration of Conformity (DoC). Ensures CE-mark on product labeling complies to the IVD-R. Participates in Site Management Reviews. Ensures reporting requirements are met.
Acts as the primary point of contact for Regulatory-related communication with the Notified Bodies or Competent Authorities.
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DUNNE Lynsey
PRRC (Quality): Ensures conformity of devices is appropriately checked before a device is released. Participates in Site Management Reviews. Oversight of PMS system. Ensures Internal Quality Agreements are in place. Approves Declaration of Conformity. Participates in design control pre-market reviews. Acts as the primary point of contact for Quality-related communication with the Notified Bodies or Competent Authorities.
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WHITNEY Lorraine
PRRC (Regulatory): Ensures that technical documentation and Declarations of Conformity are drawn up and kept up-to-date
Approves Declaration of Conformity (DoC). Ensures CE-mark on product labeling complies to the IVD-R. Participates in Site Management Reviews. Ensures reporting requirements are met.
Acts as the primary point of contact for Regulatory-related communication with the Notified Bodies or Competent Authorities.
Hidden
LENNON John
PRRC (Quality): Ensures conformity of devices is appropriately checked before a device is released. Participates in Site Management Reviews. Oversight of PMS system. Ensures Internal Quality Agreements are in place. Approves Declaration of Conformity. Participates in design control pre-market reviews. Acts as the primary point of contact for Quality-related communication with the Notified Bodies or Competent Authorities.