Executives & regulatory representatives of Bio-Rad Laboratories Inc.
2 contacts identified
MCLELLAN Gabriela
- Ensure technical documentation and EU DOC are drawn up and kept up-to-date: Approve CE IVD technical files; Approve EU DOC.
- Ensure compliance to reporting of adverse events and field safety actions: Approve of adverse event reports; Approve field safety action reports.
In the case of interventional clinical performance studies or other performance studies involving risk for the subjects, person that can sign a statement to the safety of the subjects.
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BIALAS Sarah
Ensure conformity of devices is checked according with QMS requirements before a device is released: Approve product packaging and QC procedures. Approve significant deviations to production and QC procedures. Approve batch records and/or travelers.
Ensure post-market surveillance (PMS) compliance and obligations: Approve PMS plans, PMS reports and periodic safety update reports