MDC Associates (MDC) is delighted to be attending the upcoming BIVDA Regulatory Affairs Seminar, where the team will highlight its unique position as a U.S.-based CRO partner helping UK and European diagnostic innovators successfully navigate the complexities of the American regulatory landscape.
For over three decades, MDC has been the trusted partner for companies developing in vitro diagnostics. With deep expertise in clinical research, regulatory strategy, and quality systems, MDC has guided innovators through more than 150 successful FDA submissions and managed over 100 clinical studies across diverse therapeutic areas.
Helping UK Innovators Overcome U.S. Market Challenges
For many UK-based IVD companies, the U.S. market represents both the largest commercial opportunity and the greatest regulatory challenge. Differences in expectations between the MHRA and FDA, the need for robust U.S.-based clinical evidence, and the complexity of 510(k), De Novo, and PMA pathways often create hurdles that delay or derail market entry.
MDC bridges this gap by:
- Designing clinical trials to generate the evidence for both U.S. FDA and CE-IVDR market authorization.
- Anticipating FDA expectations that differ from UK or EU regulators.
- Guiding regulatory strategy to select the most efficient submission pathway.
- Supporting quality system alignment with FDA’s QSR and ISO standards.
- Providing on-the-ground expertise from a team deeply experienced in U.S. regulatory culture.
“Our U.S. base gives us a unique perspective,” said Joen Johansen, President and CEO of MDC Associates. “We understand the challenges UK and EU companies face when entering the American market, and we know how to translate their innovations into successful FDA submissions. Our goal is to give UK and EU innovators the clarity and confidence they need to expand globally.”
Clinical Expertise That Delivers Results
The MDC’s team has managed central lab, point-of-care and at-home test clinical studies across infectious disease, clinical chemistry, oncology, allergy, and women’s health, ensuring that trial design, execution, and data integrity meet the highest standards. By combining clinical precision with regulatory foresight, MDC reduces risk and accelerates time to market for UK companies seeking U.S. clearance.
About MDC Associates
MDC Associates is a U.S. based consultancy and CRO specializing in regulatory affairs, clinical research, and quality systems for in vitro diagnostics companies. With over 30 years of experience, MDC has delivered more than 150 FDA submissions and managed over 100 clinical studies, helping companies worldwide bring life-changing technologies to patients.
Contact MDC 📧 info@mdcassoc.com 🌐 www.mdcassoc.com 📍 48 Dunham Ridge Rd, Suite 4000, Beverly, MA 01915, USA
