Semi Med

Internationally-recognized in design & development of novel diagnostic & therapeutic medical devices, Precision medicine and targeted therapy.

Services

Technology Development

Product Innovation and Delivery
Program and Project management
Analytical Performance Validations
Design Transfer
Manufacturing Scale-up
Technical RCA and Problem Solving

Product Ideation

Technology Evaluation
KOL Engagement
Market Analysis
Investigating scientific strategies
Transferring projects from Bench-top to clinical trials and Market

Clinical Study Management

Phase I-III clinical trial management
Evaluation of pre-clinical studies
Root cause analysis of deviations and adverse events

Regulatory and Quality Support

Regulatory Strategy Development
ISO 13485, 21CFR Part 820, IVDR and FDA support
Audit Supporting

Support

Executive Support (Especially for SMEs)
Business Development Support

Dr. Eli Nabavi

With a number of scientific and managerial positions over a 13-year career in medical devices, Eli has led product development teams around the world for leading OEMs and Start-up SME’s.

She has conducted and managed multi-centre Phase I-III clinical trials in cooperation with large multi-nationals (Pfizer, Amgen, BioNTech) as part of their development programmes for novel drugs as Companion Diagnostics.

As well as taking a range of innovative medical devices to market, Eli has led Regulatory teams to deliver project and programs on time and on budget according to IDVR and FDA requirements and regulations.

Eli leads Medical Device Product Development and Regulatory Projects.