Dr. Tina Amini

Medical Device Division Director Founder, Managing Director
NDA Group AB, UK
Dr. Tina Amini is the director of medical device divison at NDA Group AB where she has been supporting MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products. Tina formerly held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor. Tina was also involved in the classification of borderline products, EU pre-submission scientific advice procedures for medical devices, the consultation process with several EU competent authorities and EMA for device/drug products. She was a member of Team-NB Working Group: Borderline issues and new technologies, Classification and borderline; Post Market and Clinical. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry on the development of medicinal products and combination products in several therapeutic areas.

Events/Masterclasses Dr. Tina Amini is currently speaking at

Pharma

Quality & Regulatory Requirements for Drug Device Combination Products
13. - 15. October 2021
Online Live Stream | 8:30 – 12:30 CET
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.

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Dr. Tina Amini
Medical Device Division Director Founder, Managing Director
NDA Group AB, UK
Dr. Tina Amini is the director of medical device divison at NDA Group AB where she has been supporting MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products. Tina formerly held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor. Tina was also involved in the classification of borderline products, EU pre-submission scientific advice procedures for medical devices, the consultation process with several EU competent authorities and EMA for device/drug products. She was a member of Team-NB Working Group: Borderline issues and new technologies, Classification and borderline; Post Market and Clinical. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry on the development of medicinal products and combination products in several therapeutic areas.
Dr. Tina Amini
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