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

ClariMed Achieves ISO 13485:2016 Certification

Introduction

ClariMed, Inc., recognized globally for its innovative human-centered medical device development, has achieved a pivotal milestone by obtaining the ISO 13485:2016 certification through the British Standards Institution (BSI). This achievement reflects the company's unwavering commitment to excellence in quality management and its ambition to expand its global footprint within the medical technology sector.

Significance of the Certification

Achieving the ISO 13485:2016 certification is of monumental significance for ClariMed as it enables the organization to enhance its offerings to both emerging startups and established multinational pharmaceutical and medical technology firms. By adhering to this recognized international standard, ClariMed is poised to deliver high-quality services across consultancy in regulatory affairs, quality management systems, and the design and development of medical devices and in-vitro diagnostics.

Expanding Capabilities

The certification not only signifies compliance with global standards but also broadens ClariMed's scope of services to meet the evolving needs of the MedTech and pharmaceutical sectors. As regulations become more stringent around the world, this certification allows ClariMed to introduce a more diversified range of services, including human factors research, usability studies, strategic advisory, and quality management—all while emphasizing stringent quality benchmarks that aid clients in speeding up their market entry.

Leadership Perspectives

Kelley Kendle, the Chief Executive Officer of ClariMed, shared her insights on this achievement: "This certification reflects our collective dedication to maintaining quality processes over the past three years. Our team's consistent growth, now reaching 70 professionals across five global offices, mandates that we uphold uniform quality standards. The ISO 13485 certification gives our clients assurance that they will experience exceptional service regardless of the location they are collaborating with us from."

Client Benefits

Among the numerous advantages, ClariMed's ISO 13485 certification allows the firm to :

• - Enhance credibility in regulatory submissions to governing bodies such as the FDA and EU MDR.
• - Standardize processes that minimize project risks, enhancing overall effectiveness and reliability.
• - Deliver consistent high-quality outputs across all office locations.
• - Leverage certification benefits to ensure quality is embedded in every project.

Liz Wellwood, the Director of Quality at ClariMed, emphasized the operational advancements brought by the certification. "Our ISO 13485 certification formalizes our established rigorous practices while allowing us to introduce efficiencies. Clients can look forward to improved traceability, informed risk-based decisions, and documented evidence of our relentless pursuit of continuous improvement. This certification reassures our clients that our quality standards align with theirs, fostering smoother collaborations and easier compliance."

Global Operations and Team Training

ClariMed’s expanding network, including offices in Chadds Ford, San Jose, and two locations in the UK, benefits significantly from this certification. It assures a consistent delivery of quality irrespective of geographical boundaries, aligning with the company’s goal of making innovative medical technologies accessible for diverse communities.

The ISO 13485-certified quality management system will bolster ClariMed's capabilities through:

• - Comprehensive documentation controls and records management practices.
• - Structured training initiatives designed to keep teams up-to-date with regulatory strategies.
• - Risk-based approaches to supplier management, enhancing sourcing decisions.
• - End-to-end project documentation and deliverable traceability.
• - Continuous improvement and monitoring mechanisms integrated into daily operations.

Conclusion

This certification represents a transformative moment in ClariMed's growth trajectory, equipping the company to respond to the increasing demand for sophisticated and compliant medical device development services on a global scale. As the medical device industry continues its globalization, ClariMed stands as a trusted partner, capable of delivering consistent quality and excellence across various borders and regulatory environments.

For more information about ClariMed's services or media inquiries, visit ClariMed or contact their media relations team.