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

ClariMed Inc. Earns ISO 13485 Certification

A New Milestone in Medical Device Development

ClariMed, Inc., a leading global player in the human-centered development of medical devices and regulatory services, proudly announces its recent achievement of ISO 13485:2016 certification from the British Standards Institution (BSI). This certification is not just a badge of honor; it represents a significant leap forward for ClariMed’s commitment to quality, regulatory compliance, and expansive growth in both the MedTech and pharmaceutical landscapes.

ISO 13485:2016 is a crucial standard delineating the requirements for a quality management system specific to medical devices. By adhering to these international benchmarks, ClariMed can provide enhanced value to a diversified array of clients—from nimble startups to established multinational corporations—while upholding the highest standards of quality management.

Broadening the Service Portfolio

The certification includes consultancy services across various sectors such as regulatory affairs, quality management system (QMS) development, and design for both medical device manufacturers and in vitro diagnostics. In doing so, it affirms ClariMed's extensive capability in accelerating product development processes, a necessity for organizations striving to navigate the evolving landscape of medical regulations.

ClariMed's CEO, Kelley Kendle, stated, “This certification is a testament to our team's commitment and the quality processes that we have built over the past three years. As we have grown to 70 talented professionals across five global locations, maintaining consistent quality standards has been paramount.” This growth signifies that clients can expect the same level of exceptional service and quality, regardless of whether they are interacting with teams in the United States, the UK, or other international branches.

Enhancing Client Confidence and Project Management

Achieving ISO 13485 certification strengthens ClariMed's credibility during the submission of regulatory documents to authorities such as the FDA and EU Medical Device Regulations (MDR). The standardized, verifiable processes reduce project risks and ensure that high-quality services are delivered consistently across all operational sites.

Liz Wellwood, ClariMed's Director of Quality, emphasized the operational advantages presented by the new certification: “Our ISO 13485 certification formalizes the stringent practices we have always maintained while bringing new efficiencies. Clients can expect enhanced traceability and risk-based decision-making, making our collaboration smoother and compliance simpler.” This elevated standard aligns with ClariMed's mission to make innovative, user-centered medical technologies accessible across various communities.

Supporting Global Operations

ClariMed's presence spans multiple locations, including Chadds Ford (PA), Cambridge (MA), San Jose (CA), and several in the UK (Cambridge and Leeds). The certification guarantees uniform quality standards across all offices, affirming the company's dedication to making medical innovation accessible worldwide.

The ISO 13485-certified quality management system fortifies ClariMed's global development capabilities through several key elements:

• - Comprehensive documentation control and file management to mitigate risks.
• - Structured training programs that ensure staff is updated on the latest regulatory standards.
• - Risk-based supplier management processes to ensure quality inputs.
• - End-to-end monitoring and traceability of project documentation and outputs.
• - Continuous monitoring and improvement mechanisms to maintain high service quality.

Conclusion

The achievement of ISO 13485 certification marks a crucial chapter in ClariMed's ongoing journey. With the global demand for compliant development services growing, this certification positions ClariMed as a trusted partner capable of delivering excellence across regulations and borders. As ClariMed continues to pave the way for innovative medical technologies, its commitment to operational quality ensures that patients and customers alike will reap the benefits.

For further information about ClariMed and its services, you can visit www.clarimed.com.