Independent Consultant

𝐖𝐡𝐨 𝐈 𝐚𝐦?
I help IVD companies bring innovative products to market, covering the entire product lifecycle - from concept and clinical strategy to market launch and post-market activities.

Throughout my education and professional career, every decision I made was centered around enhancing people's lives and improving their access to healthcare. With over 10 years of experience in the In Vitro Diagnostics industry, I specialized in Blood Banking, Clinical Chemistry, and Autoimmune Diagnostics. My career journey has been distinctive, taking me across various departments, including technical support, marketing, clinical and medical affairs, and post-market surveillance. This diverse experience has provided me with a unique skill set and a comprehensive understanding of every stage of product development.

𝐖𝐡𝐚𝐭 𝐈 𝐝𝐨?
I offer support in these main areas:
• Market analysis: customer needs, competition analysis, regulatory requirements, market segmentation

• Clinical Affairs: clinical strategy, planning and management of clinical studies, preparation of clinical documentation, IVDR compliance, collaboration with CROs

• Post-market activities: product training, management Investigator-Initiated studies to generate RWE, KOL recruitment and management

• Blood Banking: introduction to necessary testing performed by Blood Bank Establishments, competition analysis, sales force training, regulatory requirements

𝐇𝐨𝐰 𝐈 𝐰𝐨𝐫𝐤?
I have a great ability to prioritize, set goals and work efficiently. I am very good at analysing a situation, identifying potential shortcomings and modifying as needed. I build bridges between people and groups. I believe that everyone possesses unique strengths, and by working together, we can achieve success in any project and contribute to making the world a better place.

If you would like to learn more, please feel free to send me a DM or email me at ewa.fiorentino@gmail.com.