Salute e Benessere
ClariMed Inc. Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities
This certification represents a transformative milestone that expands ClariMed's capabilities to serve the evolving needs of the global MedTech and pharmaceutical industries. As regulatory requirements continue to evolve globally, this certification empowers ClariMed to deliver an expanded portfolio of services—from human factors research and usability studies to strategic advisory, quality management, and digital solutions—all unified by rigorous quality standards that accelerate clients' path to market.
said Kelley Kendle , CEO of ClariMed.
The certification enables ClariMed to:
Liz Wellwood , Director of Quality at ClariMed, who spearheaded the certification effort, emphasized the operational benefits: "
The certification particularly benefits ClariMed's expanding global operations, with offices in
Chadds Ford (PA),
Cambridge (MA), San Jose (CA), Cambridge (UK), and Leeds (UK). It ensures consistent quality standards across all locations while supporting the company's mission to make innovative, user-centered medical technologies accessible to all communities.
ClariMed's ISO 13485-certified quality management system strengthens its global medical device development capabilities through:
This certification marks a pivotal moment in ClariMed's evolution, positioning the company to meet the growing demand for sophisticated, globally-compliant medical device development services. As the industry continues to globalize, ClariMed's ISO 13485 certification ensures clients have a trusted partner capable of delivering consistent excellence across borders and regulatory jurisdictions.
ClariMed is a premier human-centered medical device development and regulatory services company that accelerates time to market, enhances patient safety, and enables innovation for pharmaceutical and MedTech teams. Our unique approach integrates human factors at the core of device development and regulatory pathways, ensuring a "quality by design" process that maximizes value for patients, customers, and shareholders. Visit us at www.clarimed.com.
For media inquiries, please contact: press@clarimed.com
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