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SS Innovations Retains Elexes as it Pursues FDA and CE Regulatory Approvals for Flagship Surgical Robotic Device
Elexes has deep experience in delivering success for companies in the medical robotic fieldFORT LAUDERDALE, FL / ACCESSWIRE / July 28, 2023 / SS Innovations
About this update from Ss Innovations International Inc.
[{"type":"text","content":"Elexes has deep experience in delivering success for companies in the medical robotic fieldFORT LAUDERDALE, FL / ACCESSWIRE / July 28, 2023 / SS Innovations International, Inc. (the \"Company\" or \"SS Innovations\") (OTC:SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces it has retained the services of Elexes as it pursues regulatory approvals for its flagship surgical robotic device, the SSi Mantra.The SSi Mantra is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective with broad-spectrum surgical applications, including cardiac surgery. The device has been granted regulatory approval by the Indian Central Drugs Standard Control Organization (CDSCO) and is clinically validated in India in more than 40 different surgical procedures.Elexes is a regulatory and quality compliance firm with a reputation for delivering excellent expert guidance and unbiased assistance. The company offers services worldwide and assists its clients in securing the approvals for breakthrough innovations. Elexes has strong expertise in approval and post market compliance of medical devices, pharmaceutical drugs, and biologics.Dr. Sudhir Srivastava, CEO, Chairman and Founder of SS Innovations, said, \"As SS Innovations prepares to pursue regulatory approvals for our SSi Mantra surgical robotic device in Europe and the United States, we are very pleased to have entered an agreement with Elexes to facilitate the process.\"Elexes has an excellent reputation and track record of success, and previously worked with some of the foundational companies in the medical robotic field, including its key personnel's experience with Intuitive Surgical and Stryker. We feel confident in the organization's ability to guide us to achieving FDA and CE approvals in 2024 and 2025.\"About ElexesElexes helps companies prepare documentation, review reports, perform risk analysis, and secure regulatory approvals. The regulatory and quality compliance firm is ISO 13485 certified by BSI Group, and establishes GMP/ISO compliant pre- and post-market systems for its clients. Elexes leverages expertise, uses cutting-edge tools for project management and effective communication while preemptively informing cli...