#USA #ISO Certification #Medical Device #Chadds Ford #ClariMed Inc

ClariMed, Inc. Achieves Significant ISO 13485 Certification

On July 29, 2025, ClariMed, Inc., renowned for its commitment to human-centered medical device development, proudly announced its achievement of ISO 13485:2016 certification. This significant milestone represents the company’s unwavering dedication to quality and its rapid expansion into global markets. The certification, awarded by BSI, empowers ClariMed in its mission to deliver top-notch consulting and regulatory services across sectors, from innovative startups to established multinational corporations.

Enhancing Value for MedTech and Pharmaceutical Companies

The certification covers critical areas including quality management systems, regulatory affairs, and both design and development services for medical devices and in-vitro diagnostic manufacturers. This broad scope allows ClariMed to offer enhanced value to clients, ensuring they receive the highest standards in service delivery.

ClariMed's CEO, Kelley Kendle, emphasized the importance of this certification, stating, "This achievement showcases our team’s commitment to excellence and the quality procedures we've established collectively. With our growing workforce of 70 talented professionals operating across five global offices, maintaining consistent quality services is of utmost importance. ISO 13485 ensures our clients, whether they are in the US, UK, or any other location, receive exceptional service quality."

Meeting Evolving Global Regulatory Standards

The global medical landscape is rapidly changing, with evolving regulatory requirements that challenge many in the industry. ClariMed’s ISO 13485 certification equips the company to meet these challenges head-on by expanding its service offerings. These include advocacy for human factors research, usability studies, and strategic advisory services, all seamlessly integrated to provide clients with robust quality management and digital solutions.

The operational advantages of ISO 13485 certification are numerous and noteworthy. Liz Wellwood, ClariMed’s Director of Quality, who led the certification efforts, highlighted that this accreditation formalizes existing rigorous processes while introducing efficiencies that can enhance client interactions.

"Clients can expect an increase in traceability and risk-based decision making, backed by documented evidence of our dedication to continual improvement. The certification assures them that our quality benchmarks align with their standards, streamlining collaboration and compliance," she stated.

Supporting ClariMed’s Global Operations

With office locations in Chadds Ford (PA), Cambridge (MA), San Jose (CA), as well as the UK, the certification will significantly benefit ClariMed as it continues to expand globally. It guarantees consistent quality across all operations, reinforcing the company’s goal of making medical technologies that prioritize user needs accessible to diverse communities.

ClariMed’s ISO 13485-certified quality management system further boosts its ability to serve an industry characterized by complexity and rapid evolution with:

• - Comprehensive documentation control for efficient records management.
• - Structured training programs that ensure employees are well-versed in the latest regulatory guidelines.
• - Risk-based supplier management processes that enhance accountability throughout the supply chain.
• - Rigorous oversight of project documentation and deliverables, ensuring consistency and reliability.
• - Continuous improvement metrics that monitor and enhance service delivery.

A Pivotal Moment for ClariMed

This certification marks a crucial step in ClariMed’s evolution, positioning it to adeptly navigate the complexities of the medical device development landscape. As the MedTech industry continues to globalize and become more competitive, clients can rely on ClariMed to be a trusted partner capable of providing consistent excellence across various regulatory environments.

ClariMed is committed to leading the way in developing innovative yet safe medical technologies. By integrating human factors into every stage of development, the company ensures that the products not only comply with regulatory expectations but also align with end-user needs and experiences, ultimately providing maximum value to patients, practitioners, and stakeholders alike.

To learn more about ClariMed and its services, please visit their website. For media inquiries, contact the company directly.