At Qserve, we take pride in our team of Regulatory and Clinical experts. Today, we are excited to introduce you to José Enrique Cabrera, Principal Consultant and US Market Expert. In his role, he supports the regulatory process for innovative, first-in-class devices, integrates clinical and scientific considerations, and ensures structured engagement with the FDA for US market access.
José is a Regulatory Affairs and quality systems leader with over 25 years of experience supporting the development, authorization, and lifecycle management of medical devices, including first-of-a-kind and clinically novel technologies. He has an educational background in Biology.
With expertise spanning regulatory strategy, clinical practice, and FDA submissions in environments where regulatory precedent is limited of evolving, he makes a valuable addition to the Qserve team, which he joined in June 2026. Helping manufacturers navigating complex U.S. market entry challenges, supporting De Novo Classifications and Q-Sub interactions, he bridges the gap between innovation and regulatory success.
Novel and Breakthrough Technologies
José’s primary area of focus is supporting innovative, first-in-class, and breakthrough devices where existing regulatory paradigms are not fully established. These programs require more than adherence to established requirements; they require the ability to:
- Define and justify new scientific and clinical constructs
- Translate device mechanisms and real-world use into regulatory frameworks
- Develop evidence strategies in the absence of direct precedent
- Engage FDA in a manner that facilitates mutual understanding and alignment
Scientific and Clinical Integration
José combines formal training in biological sciences with clinic/hospital experience to support regulatory strategies grounded in human physiology, clinical application, and risk-based evaluation.
José’s work integrates clinical and scientific considerations directly into structured deliverables, where he ensures device functionality and mechanism of action are presented with clear scientific and clinical context and that intended use, indications for use, and labeling are aligned with real-world clinical application (clinically meaningful endpoints and rationale)
This integrated approach is critical for technologies requiring enhanced scrutiny or non-traditional evidence strategies.
EU MDR to US FDA Market Entry
José is eager to provide targeted support to organizations with EU MDR-certified devices seeking entry into the US market. This includes rapid assessment of existing technical documentation and clinical evidence developed under MDR, identification of gaps relative to FDA expectations, levering existing data, and developing efficient, cost-conscious regulatory strategies. This capability is particularly valuable for organizations seeking a practical and budget-aware transition into the U.S. regulatory environment without duplicative effort.
How Qserve Can Help
From defining regulatory pathways for first-in-class technologies to translating innovative concepts into clear, reviewable submissions. We are excited to have José on board and look forward to the impact he will make in supporting manufacturers with efficient and effective pathways to the U.S. market.
Are you developing an innovative medical device or looking to streamline your transition from EU MDR compliance to U.S. FDA market access? Get in touch with our team to discuss how we can support your regulatory strategy and submission journey.