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Velentium
Velentium Employees
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Satyajit "Sat" Ketkar
Director, Systems Engineering
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Terry Daglow
VP, Advanced Mechanical & Manufacturing Engineering
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Velentium's Specializations
Velentium specializes in the end-to-end design, development, manufacturing, and post-market support of therapeutic and diagnostic active medical devices. Their core competencies span across active implantable medical devices, systems engineering, firmware & software, cybersecurity, mobile & cloud technologies, electrical & mechanical engineering, human factors & usability, automated test systems, and CGMP manufacturing. This comprehensive expertise allows Velentium to provide robust and integrated solutions tailored to the unique needs of the medical device industry.
Velentium's Certifications and Regulatory Compliance
Velentium is ISO 13485 certified and FDA-registered, ensuring that they adhere to the highest standards of quality and regulatory compliance in the medical device industry. This certification underscores Velentium's commitment to quality management systems and continuous improvement, enabling them to serve as both a contract manufacturer and manufacturer of record. Their adherence to these stringent standards ensures that all products and services meet the necessary regulatory requirements, providing clients with peace of mind and reliability.
Velentium's Contract Manufacturing Services
Velentium offers comprehensive contract manufacturing services, emphasizing CGMP production. Their design and development subject matter experts (SMEs) are available throughout the process, ensuring that every stage from conception to production meets the highest standards of quality and efficiency. This service is particularly valuable for startups seeking to bring new innovations to market rapidly and for established companies looking to scale production without compromising on quality.
Velentium's Embedded Cybersecurity Solutions
Velentium provides specialized embedded cybersecurity solutions for medical devices. Their approach focuses on design-compliant, sufficient, and right-sized security measures, ensuring that devices are protected against cyber threats while maintaining functionality and compliance with industry standards. This is crucial in the medical device sector, where data integrity and patient safety are paramount. Velentium's expertise in cybersecurity helps clients safeguard their devices against emerging threats and regulatory scrutiny.
Velentium's Global Operations and Client Base
Velentium operates on a global scale, collaborating with a diverse range of clients from startups in need of seed funding to established Fortune 500 companies. This extensive reach demonstrates Velentium's versatility and capability to address the unique needs of various market segments. By leveraging their comprehensive expertise and global footprint, Velentium is able to provide tailored solutions that help clients navigate the complexities of the medical device industry and achieve their business objectives.
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