ClariMed, Inc., a global leader in human-centered medical device development and regulatory services, announced it has achieved ISO 13485:2016 certification through BSI. This significant milestone underscores the company’s commitment to quality excellence and further strengthens its global service capabilities for the MedTech and pharmaceutical industries.
The certification validates ClariMed’s comprehensive consultancy services across quality management systems, regulatory affairs, and the design and development of medical and in-vitro diagnostic devices. It reflects the company’s ability to meet the highest international standards for quality management, ensuring consistent, high-quality deliverables across all client engagements—whether supporting a nimble startup or a multinational enterprise.
“This certification is a testament to our team’s dedication and the robust quality processes we’ve built over the past three years,” said Kelley Kendle, CEO of ClariMed. “With 70 professionals across five offices in the US and UK, maintaining unified standards has been vital to our success. ISO 13485 assures our clients that they will receive the same exceptional level of service—no matter where they engage with us.”
The certification enhances ClariMed’s ability to support clients navigating increasingly complex global regulatory landscapes, including submissions to the FDA, EU MDR, and other international bodies. It introduces new operational efficiencies and formalises rigorous processes that have long been embedded in the company’s culture.
Liz Wellwood, Director of Quality at ClariMed and the driving force behind the certification effort, noted the operational significance: “ISO 13485 allows us to elevate our quality framework while making it more traceable, risk-informed, and aligned with our clients’ expectations. It gives our partners the confidence that our standards match theirs, enabling more seamless collaboration and efficient compliance.”
The certification also strengthens ClariMed’s expanding global footprint, which includes offices in Chadds Ford (PA), Cambridge (MA), San Jose (CA), Cambridge (UK), and Leeds (UK). It enables a unified, auditable system of quality across all locations, reinforcing the company’s mission to bring innovative, user-centred medical technologies to market with speed, safety, and precision.
ClariMed’s certified quality management system now supports an even more robust infrastructure—enhancing documentation control, training, supplier oversight, and continuous improvement. As the medical device industry continues to globalise, this achievement positions ClariMed as a trusted partner delivering compliance, consistency, and excellence across borders.
