My team of experienced professionals in R&D, Production, QC, QA/RA, and medical writers, along with myself, specialize in the custom development of PCR kits up to the CE IVD certification stage, in compliance with IVDR. Together, we can successfully guide your medical project to its goal. I will oversee the entire process, from concept to market launch. With my team and your experts, we’ll actively collaborate to achieve our common objective. Everything will be managed according to the latest project management methods (Agile, PRINCE2, remote), IVDR regulations, and ISO 13485, ensuring an efficient and enjoyable experience throughout.