Carlos Galamba, IVD Consultant – MDx CRO Founder
In the intricate landscape of In Vitro Diagnostics (IVD) and the evolving In Vitro Diagnostics Regulation (IVDR), one name stands out as a beacon of expertise and guidance – Carlos Galamba. With a wealth of experience spanning over 18 years in the IVD sector, Carlos is a seasoned consultant who has left an indelible mark on the world of diagnostics.
Pioneering Path to Regulatory Mastery
Carlos’s journey commenced as a biomedical scientist, setting the stage for a remarkable career journey. His trailblazing role as the first in-house clinician for IVDs at BSI (British Standards Institution), a renowned Notified Body, played a pivotal role in shaping the clinical oversight process for hundreds of diagnostics. From genetic tests to molecular assays, point-of-care diagnostics, CDx, LDTs / in-house assays, NGS and beyond, Carlos expertise is unrivaled. This groundbreaking contribution has significantly impacted how the industry approaches regulatory compliance.
Mastering the IVDR Landscape
Carlos Galamba’s expertise extends well beyond his role at BSI. His insights have positioned him as a distinguished external expert for the EU Commission, where he provides invaluable guidance in navigating the intricate IVDR terrain. His strategic acumen has propelled prominent companies like Biomerieux, Cepheid, Leica, Hologic, Abbott, Thermofisher, Werfen and more toward achieving excellence in IVDR compliance.
Guiding Innovation in IVD
At the helm of innovation, Carlos Galamba served as the Vice President of IVD Intelligence & Innovation at RQM+. His technical thought leadership encompassed an array of IVD technologies, ranging from immunoassays to more complex next-generation sequencing tests and IVD Software. Carlos’s insights have led to the development of competitive intelligence strategies that drive expansion and commercialization within the IVD consultancy sector.
A Catalyst for Regulatory Success
Carlos’s dedication to simplifying the complex is the cornerstone of his approach. His tailored solutions empower businesses to navigate the evolving regulatory landscape while gaining a competitive edge. His remarkable achievements, including leading the transition to the new EU medical device legislation (IVDR) at several global companies and successfully implementing pivotal regulatory changes, position Carlos Galamba as a catalyst for transformative IVD projects.
Connect with MDx CRO for Regulatory Excellence
Whether you’re an IVD startup with ambitious goals or a global diagnostics manufacturer looking to streamline regulatory processes, Carlos Galamba’s expertise is your compass for regulatory mastery. If your company is seeking unparalleled IVD consulting, don’t hesitate to connect with Carlos and his team at MDx CRO. Together, they bring a wealth of knowledge to guide you through the complexities of IVD regulations.
Connect with Carlos on LinkedIn: Carlos Galamba’s LinkedIn Profile
In the intricate world of In Vitro Diagnostics and the evolving IVDR, Carlos Galamba’s expertise illuminates the path toward regulatory excellence. His journey serves as a testament to the profound impact of guidance and knowledge in the field of IVD consultation and IVDR compliance.
