Velentium

Services

Velentium offers a comprehensive suite of services centered around the design, development, manufacturing, and post-market support of active medical devices. The company provides industry-specific expertise in areas such as systems engineering, firmware & software, and electrical & mechanical engineering. They also deliver embedded cybersecurity solutions and automated test systems. These services are supported by their CGMP manufacturing processes and ISO 13485 certification.

Specialization in Active Implantable Medical Devices

Velentium excels in the design and development of active implantable medical devices. Their core competencies include developing systems that adhere to rigorous standards, ensuring compliance with industry requirements, and integrating state-of-the-art cybersecurity measures. The firm's expertise spans various aspects of device creation, from initial concept to final product and post-market activities.

ISO 13485 Certification and FDA Registration

Velentium is ISO 13485 certified and registered with the FDA, affirming its capability to meet strict quality standards essential for medical device manufacturing. This certification underlines their reliability in producing safe and effective medical devices. The company can function both as a contract manufacturer and as the manufacturer of record, providing full lifecycle support.

Embedded Cybersecurity Solutions

Velentium offers robust embedded cybersecurity solutions tailored for medical devices. These solutions are designed to be compliant, precise, and appropriately scaled to the needs of the device in question. They ensure that the medical devices are secure from unauthorized access and vulnerabilities, adhering to the highest industry standards.

Global Operations and Client Range

Velentium operates globally, working with a diverse array of clients. Their clientele includes both emerging startups that are in the preliminary stages of development and well-established Fortune 500 companies. This wide range of operations highlights Velentium's capability to scale their services according to the unique needs of each client, ensuring tailored support and strategic partnership.