ClariMed Inc.

ClariMed Inc. is a medical device consulting firm that specializes in human factors engineering, regulatory compliance, and quality management for medical device manufacturers, pharmaceutical companies, and combination product developers. The company operates from seven offices across the United States and Europe, with headquarters in Chadds Ford, Pennsylvania.

The firm provides end-to-end support for medical device development, including user needs assessments, contextual inquiries, usability validation testing, and regulatory submissions. Their service portfolio spans human factors studies, quality management system implementation, digital solutions including UI/UX design and cybersecurity, and strategic advisory services for navigating FDA and international regulatory pathways. ClariMed maintains ISO 13485:2016 certification and employs a multidisciplinary team with backgrounds in human factors, biomedical engineering, psychology, and quality engineering.

The company offers flexible engagement models including project-based consulting, embedded resources, retainer arrangements, and comprehensive end-to-end solutions. ClariMed also operates ClariMed University, an educational platform, and conducts paid user research studies to inform medical device design.

Organizations should consider ClariMed when they need specialized medical device development expertise that integrates human factors principles with regulatory strategy. The firm's ISO 13485 certification and global office network make them particularly valuable for companies navigating both FDA and international regulatory pathways simultaneously.

ClariMed's embedded resource model allows clients to augment internal teams with specialists in areas like usability engineering, quality assurance, or cybersecurity without committing to full-time hires. Their multidisciplinary team composition enables rapid onboarding to novel technologies and integration with existing quality systems.

ClariMed operates exclusively within the medical device, in vitro diagnostic, and combination product sectors of healthcare. Their services are specifically tailored to meet FDA human factors validation requirements, EU MDR compliance, and international medical device regulations. The company's expertise spans multiple therapeutic areas and device types, from surgical instruments and drug delivery systems to connected medical devices requiring cybersecurity validation.

Their ISO 13485:2016 certification demonstrates specialization in medical device quality management systems, while their study facilities are designed specifically for conducting FDA-compliant formative and summative usability studies with healthcare professionals and patients as intended users.

The ideal client is a medical device manufacturer, pharmaceutical company developing combination products, or IVD developer who requires specialized regulatory and human factors support. This includes early-stage companies bringing novel technologies through regulatory approval, mid-size manufacturers needing validation study execution, and established MedTech firms requiring strategic advisory for complex regulatory pathways or augmentation of internal quality and usability teams.