RQM+ is excited to announce the addition of Carlos Galamba as IVD Director after several years working for one of the largest Notified Bodies leading a global IVD team and assisting in the IVDR transition efforts.
Carlos joins RQM+ after seven years at BSI where he was responsible for managing, coaching, and developing a global team of IVD technical experts in his role as a Technical Team Manager. Among many of Carlos’s achievements, he was BSI’s first in-house clinician for IVDs where he led the implementation of the BSI clinical oversight process and has made hundreds of CE marking recommendations for IVDs.
At BSI he supported and led IVDR Notified Body designations, was responsible for the development of clinical procedures, technical guidance for BSI reviewers, and consulted on MDCG draft guidance prior to publication, including for example IVD batch verification, summary of safety and performance, IVD classification rules and performance evaluation for SARS-CoV-2.
Prior to BSI, Carlos has held roles at the UK competent authority, the MHRA, and was a senior biomedical scientist in the UK National Health System, working for some of the largest IVD clinical laboratories including Imperial College and University College of London Hospitals. Carlos has a background in haematology, clinical chemistry and haemostasis and specializes in high-risk class D IVDs including those used in the fields of transfusion and transplantation.
A Passion for Diagnostics
With a background in biomedical sciences and extensive work conducted at the forefront of diagnostics, Carlos is passionate about the impact of IVDs in patient management.
In his past clinical experience, he worked with some of the highest risk IVDs, used in both routine and emergency settings, where he diagnosed and monitored a variety of clinical conditions, spanning from haemoglobinopathies and transfusion screening to infectious diseases and blood cancer, for example.
He was also a member of the London transfusion committee where he collaborated with the National Blood Service in their efforts to substantially improve clinical outcomes for patients and to promote safe transfusion practices in the UK.
Through diagnostics, Carlos has helped change thousands of lives; for instance, he was at the forefront of the Ebola crisis in 2014 when the first cases were detected in Europe and played a key role in hospital and laboratory preparedness for emerging infectious diseases. Equally, Carlos was also involved in reviewing the first HIV self-tests CE marked in Europe.
Having worked in highly specialized, high-risk fields, such as bone marrow and liver transplantation, where diagnostics can dictate the difference between life and death, he knows too well the impact a good or a bad test can make on a patient’s clinical outcome and the risks involved. For that reason, Carlos is fully committed to improving the quality of diagnostics and bringing safe and reliable products to market.
An Asset to RQM+
Carlos will be working with the Intelligence & Innovation team providing thought leadership and helping to drive technical quality for in vitro diagnostics.
Coming from both a technical and clinical leadership role at BSI exclusively dedicated to IVDs, Carlos is in a unique position to influence best practices in the sector. Not only did he implement Notified Body processes for both the IVD Directive and Regulation, he also created technical content and position statements that are used by BSI reviewers in the assessment of IVD CE files which make him a pivotal asset for RQM+.
At BSI, Carlos reviewed a wide range of IVD products in all classes, spanning from complex, cutting-edge technologies such as molecular and next-generation sequencing to immunoassays, flow cytometry, and immunohistochemistry, for example. He is a true all-rounder when it comes to diagnostics, someone that can easily navigate around regulatory hurdles. He will be leading at the forefront of innovation across several functions of the business, including marketing, business development, training, and consultancy services.
Why RQM+ is the Right Fit
For Carlos, RQM+ means working with a growing company that is at the leading edge of innovation for medical devices and IVDs. He is excited to be in a position where he can influence change and drive up quality for in vitro diagnostics through the large customer base of RQM+.
He is proud to have joined an organization where he can continue his endeavors to improve the standard of IVDs, whilst working flexibly and with an incredibly talented workforce, one that has quality and safety at the core of everything they do.
Top Challenges in IVDR Transition
The IVDR brings in substantial changes in place of the IVDD that had directed the landscape up until now. The level of scrutiny for IVDs has markedly increased with far greater Notified Body oversight and several regulatory hurdles to overcome, in the form of EU consultations and expert panel reviews for the highest risk products.
The lack of robust infrastructure to support the transition is a major concern. EUDAMED and EU Reference labs preparedness, lack of MDCG guidance particularly around clinical evidence, and more importantly Notified Body capacity are some of the key challenges that the industry faces. With only six Notified Bodies designated under the IVDR and less than a year to the date of application, there is simply not enough resource available to ensure products currently on the market are CE marked before the deadline. With a ten-fold increase in the number of devices needing a certificate under the IVDR, there is a real risk of significant disruption to the supply chain, severely impacting clinical decisions for millions of EU patients that rely on diagnostics.
Unsurprisingly, several industry and patient groups have called for a delay to the date of application. Even if a delay is granted, it will still need to be passed into European law. For manufacturers, this certainly does not mean delaying their transition efforts any further. A delay to the date of application is probably the only opportunity manufacturers will have to keep their existing products on the market. Planning is everything right now!
How RQM+ Can Help
Carlos brings even more IVD experience and expertise to the RQM+ team. Our client-validated IVDR transition processes, procedures, and tools can help you efficiently achieve compliance and add value to your business at the same time. We know that the IVDR process can be overwhelming and planning now is a critical factor. With our proactive approach, RQM+ helps IVD manufacturers stay ahead with transformative solutions that integrate systems and add efficiencies to improve your business as a whole.
Learn more about our IVD services and how RQM+ can help your team.