Regulatory Affairs Consultant
Miriam Kinsella is a Regulatory Affairs Consultant at Trinzo. Miriam is based in
County Wicklow, Ireland, and has over 10 years experience in the IVD industry.
Miriam’s experience has involved the creation of technical documentation and CE Marking of new devices, through to worldwide market registration. Miriam also has
experience in regulatory impact assessments, and internal auditing according to
ISO 13485 and MDSAP requirements.
More recently, Miriam has worked on the transition to the IVD Regulation, including
conducting gap analyses, compilation of technical documentation, and updating
of QMS documentation, ensuring compliance to IVDR requirements.