#USA #Medical Devices #ClariMed #Chadds Ford #ISO 13485

ClariMed Inc. Achieves ISO 13485:2016 Certification

ClariMed, Inc., a recognized global leader in the development of human-centered medical devices and regulatory services, has recently announced its achievement of the ISO 13485:2016 certification, awarded by BSI. This certification marks a pivotal advancement in ClariMed's commitment to quality excellence and global expansion in the medical device industry.

The ISO 13485:2016 certification allows ClariMed to enhance its value proposition to a diverse clientele, including innovative startups and multinational corporations within the pharmaceutical and MedTech sectors. By adhering to the highest standards in quality management, ClariMed demonstrates its dedication to providing exceptional services across its comprehensive portfolio, which includes regulatory affairs consulting, design and development services, and in vitro diagnostic medical device support.

According to Kelley Kendle, CEO of ClariMed, this certification is a testament to the dedication and rigorous quality processes established by the team's collective efforts over the past three years. As the organization has grown to a team of 70 talented professionals spread across five global offices, maintaining consistent quality standards has been crucial. Kendle stated, “ISO 13485 assures our clients that they will receive the same exceptional level of service and quality, regardless of whether they work with our teams in the United States, the UK, or beyond.”

The scope of this certification extends beyond just compliance; it reinforces ClariMed’s credibility regarding regulatory submissions to agencies such as the FDA and EU MDR, while also minimizing project risks through standardized and verifiable processes. It ensures that ClariMed can continuously deliver high-quality, consistent products across all its offices while also leveraging this recognition to instill confidence in clients.

Liz Wellwood, ClariMed's Quality Director who spearheaded the certification effort, emphasized the operational benefits associated with ISO 13485. She noted, “Our certification formalizes the rigorous processes we have always maintained. Clients can now anticipate better traceability, risk-based decision-making, and documented evidence of our commitment to continuous improvement.” This assurance allows for enhanced collaboration and simplifies compliance for clients.

ClariMed's global reach is further solidified by this certification, which encompasses the organization's offices in Chadds Ford, PA; Cambridge, MA; San Jose, CA; Cambridge, UK; and Leeds, UK. The certification guarantees consistent quality standards across all locations while supporting the company's mission of making innovative, user-centered medical technologies accessible to diverse communities.

The robust quality management system implemented at ClariMed includes thorough documentation control, structured training programs to ensure team expertise in the latest regulatory trends, risk-based supplier management processes, and comprehensive oversight and traceability of project documentation and deliverables. Furthermore, mechanisms for ongoing monitoring and improvement have been integrated to maintain high standards.

As ClariMed positions itself to meet the increasing demand for sophisticated medical device development services that adhere to international standards, the ISO 13485 certification serves as a reassurance to clients that they have a reliable partner capable of delivering consistent excellence across borders and regulatory jurisdictions.

About ClariMed

ClariMed is a human-centered regulatory services and medical device development company that accelerates market access and enhances patient safety while fostering innovation for pharmaceutical and MedTech teams. Its unique approach places 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. For more information, visit www.clarimed.com.