ClariMed Inc. Achieves ISO 13485:2016 Certification, Strengthening Global Medical Device Development Capabilities

Chadds Ford, PA – July 29, 2025 -- ClariMed, Inc., a global leader in human-centered medical device development and regulatory services, today announced it has achieved ISO 13485:2016 certification through BSI, marking a significant milestone in the company's commitment to quality excellence and global expansion. The certification positions ClariMed to deliver enhanced value to MedTech and pharmaceutical companies—from innovative startups to global multinationals—while maintaining the highest standards of quality management.

The certification scope encompasses consultancy services in the area of quality management systems, regulatory affairs, design and development for medical devices and in-vitro diagnostic medical device manufacturers, validating ClariMed's comprehensive service portfolio.

This certification represents a transformative milestone that expands ClariMed's capabilities to serve the evolving needs of the global MedTech and pharmaceutical industries. It signals to the industry that ClariMed operates with the same rigorous quality standards expected of the world's leading medical device companies, creating new possibilities for collaboration and innovation. 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.

"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," said Kelley Kendle, CEO of ClariMed. "As we've grown to 70 talented professionals across five global offices, maintaining consistent quality standards has been paramount. ISO 13485 provides our clients with confidence that whether they're working with our teams in the US, UK, or anywhere else, they'll receive the same exceptional level of service and quality. It's particularly meaningful as we support clients navigating FDA, EU MDR, and other global regulatory pathways—this certification ensures we're speaking the same quality language as our clients and the regulators."

 The certification enables ClariMed to:

• Strengthen credibility for regulatory submissions to FDA, EU MDR, and other global regulatory bodies

• Minimize project risks through standardized, auditable processes

• Deliver consistent, high-quality deliverables across all office locations

• To leverage our ISO 13485 certification for clients

• Ensure quality is built into every project

Liz Wellwood, Director of Quality at ClariMed, who spearheaded the certification effort, emphasized the operational benefits: "Our ISO 13485 certification formalizes the rigorous processes we've always maintained while introducing new efficiencies. Clients can expect enhanced traceability, risk-based decision making, and documented evidence of our commitment to continuous improvement. This certification assures them that our quality standards match their own, making collaboration more efficient and compliance more straightforward."

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:

• Comprehensive documentation control and records management

• Structured training programs ensuring team expertise in latest regulatory guidance

• Risk-based supplier management processes

• End-to-end oversight and traceability of project documentation and deliverables

• Continuous monitoring and improvement mechanisms

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.

About ClariMed

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.

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