Tina joined NDA in December 2019 and since has been supporting MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products. She has successfully helped companies to identify the correct regulatory pathway for their borderline products and classification of their devices in US and EU and assisted clients in selection and interaction with Notified Bodies for certification of medical devices. She has supported clients in obtaining Notified Body reports for the device aspect of integral drug-device combination product under new Medical Device Regulation, Article 117.
Key Areas Of Expertise
- Regulatory Expertise in EU Medical Device Regulation (MDR) and EU In-vitro Diagnostic Regulation (IVDR)
- Borderline classification
- Article 117 of EU MDR; Compliance and approval of combination products
- Quality Management System & ISO 13485:2016 lead auditor
- Led multiple Quality Management System audits of Medical Device Manufacturers as part of CE certification including unannounced audits
- Request for Designation (Pre-RFD/RFD), 510(k) and PMA application in the US
- Preparation of Clinical Evaluation plans & reports, Post Market Surveillance plans & reports including Post Market Clinical Follow up (PMCF/PMPF) for medical device sectors
- Conducted assessment of several clinical evaluation reports as part of conformity assessment
- Successfully prepared several clinical evaluation plans and reports which were accepted by Notified bodies
- Preparation and assessment of Ancillary Medicinal Substance Technical Documentation and Submission to EU Competent Authorities and/or EMA
- Have reviewed and submitted over 50 consultation documentation to EU Competent Authorities and/or EMA
Tina 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
- Medical devices and their growing regulatory challenges
- New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics