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

ClariMed Inc. Achieves ISO 13485:2016 Certification

ClariMed, Inc., a global leader in human-centered medical device development and regulatory services, has announced a significant achievement: the company has successfully obtained the ISO 13485:2016 certification through BSI. This milestone underscores ClariMed's dedication to quality excellence and its global expansion efforts.

The certification positions ClariMed to deliver enhanced value to a diverse range of clients in the MedTech and pharmaceutical sectors, from innovative startups to large multinational corporations, all while adhering to the highest quality management standards. The scope of the certification encompasses consulting services related to quality management systems, regulatory affairs, and the design and development of both medical devices and in-vitro diagnostic devices, effectively validating ClariMed's comprehensive service portfolio.

This certification marks a transformative milestone that bolsters ClariMed's capabilities to meet the evolving needs of the global MedTech and pharmaceutical industries. As global regulatory requirements continue to develop, this certification empowers ClariMed to offer an expanded portfolio of services. These services range from human factors research and usability studies to strategic consulting, quality management, and digital solutions, all unified by stringent quality standards designed to expedite clients' pathways to market.

Kelley Kendle, CEO of ClariMed, emphasized the significance of this certification, stating, "This achievement is a testament to our team's dedication and the quality processes we have developed collectively over the past three years. As our team has grown to 70 talented professionals across five global offices, maintaining consistent quality standards has been paramount. The ISO 13485 certification provides our clients with the assurance that whether they are working with our teams in the USA, UK, or elsewhere, they will receive the same exceptional level of service and quality."

With ISO 13485 certification, ClariMed strengthens its credibility for regulatory submissions to the FDA, EU MDR, and other global regulatory bodies, while also minimizing project risks through standardized and auditable processes. The certification ensures consistent, high-quality deliverables across all office locations, enabling clients to leverage ClariMed's ISO 13485 certification as a badge of reliability in their projects.

Liz Wellwood, ClariMed's Quality Director and leader of the certification effort, highlighted the operational benefits of this certification. "Our ISO 13485 certification formalizes the rigorous processes we have always maintained, while also introducing new efficiencies. Clients can expect improved traceability, risk-based decision-making, and documented evidence of our commitment to continuous improvement. This certification ensures that our quality standards align with theirs, making collaboration more efficient and compliance easier."

This certification particularly benefits ClariMed’s expanding global operations, which include 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 of making 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 and record management controls.
• - Structured training programs that ensure team expertise in the latest regulatory guidance.
• - Risk-based supplier management processes.
• - End-to-end oversight and documentation traceability of project deliverables.
• - Continuous monitoring and improvement mechanisms.

This certification signifies a crucial moment in the evolution of ClariMed, positioning the company to meet the increasing demand for sophisticated, compliant medical device development services on a global scale. As the industry continues to globalize, ClariMed’s ISO 13485 certification guarantees clients a trusted partner capable of delivering consistent excellence across borders and regulatory jurisdictions.

About ClariMed

ClariMed is a leading company specializing in human-centered medical device development and regulatory services, committed to accelerating time-to-market, enhancing patient safety, and enabling innovation for pharmaceutical and MedTech clients. Our unique approach integrates human factors at the center of device development and regulatory pathways, ensuring a 'quality by design' process that maximizes value for patients, customers, and stakeholders. Visit us at www.clarimed.com.