CHADDS FORD, PA — ClariMed, Inc. has earned ISO 13485:2016 certification through BSI, a key benchmark in quality management for medical technology developers. The certification underscores the company’s readiness to support both emerging startups and global enterprises with consistent, high-standard services across its international offices.
The certification validates ClariMed’s expertise in quality management systems, regulatory affairs, and product development for medical devices and in-vitro diagnostics. It also affirms the company’s ability to deliver structured, compliant services that align with stringent global regulations.
According to CEO Kelley Kendle, the achievement reflects years of deliberate investment in building a unified, high-performance quality culture. “This certification is a testament to our team’s dedication and the quality processes we have built as a collective team over the past 3 years,” Kendle said. “As we’ve grown to 70 talented professionals across five global offices, maintaining consistent quality standards has been paramount.”
The ISO 13485 framework is widely recognized by regulators including the U.S. Food and Drug Administration and the European Medicines Agency. For clients, this means improved regulatory credibility, reduced project risk, and standardized deliverables—regardless of which ClariMed office they work with.
Director of Quality Liz Wellwood, who led the certification initiative, noted that the move brings both assurance and operational efficiency. “Our ISO 13485 certification formalizes the rigorous processes we’ve always maintained while introducing new efficiencies,” Wellwood explained. “Clients can expect enhanced traceability, risk-based decision making, and documented evidence of our commitment to continuous improvement.”
With offices in Pennsylvania, Massachusetts, California, and the UK, ClariMed’s certified quality management system helps ensure seamless execution across borders. The company can now more confidently support global regulatory submissions, implement risk-based supplier management, and maintain end-to-end documentation oversight.
This milestone supports ClariMed’s broader mission: to make user-centered medical technologies more accessible, effective, and safe for patients worldwide.
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