Visakh Kumar's Contact Details

Visakh Kumar's Company Details

Elexes Medical Consulting LLC

Dublin, California, United States • 11 - 50 Employees
Medical Device

Elexes was born to help Entrepreneurs, Medical Device, Drugs and Biologics Companies meet regulatory and quality standards, overcome regulatory hurdles, stay in compliance, and launch their break through products into the US, EU, Indian and other international markets. Why choose Elexes: High quality Competitive pricesReduced time to the marketFrequent updates on project statusHighly dedicated and committed team of professionalsMedical Devices Across the world, Medical Devices are regulated by several regulatory bodies. A Medical Device life-cycle consists of different phases, and at each phase a Manufacturer must comply with regulatory standards and requirements laid out by the country specific regulatory bodies. Elexes is well experienced in all the phases of a Medical Device life-cycle: Elexes supports companies in defining product specifications, design inputs, outputs and testing needed at the prototype phase, testing and protocol and report writing at the preclinical and clinical stage, regulatory clearance/approval before the marketing phase, and finally at the commercial use phase, meeting compliance requirements to ensure continued safety and effectiveness of products.Foods and CosmeticsThe following categories of foods and cosmetics are regulated.Foods:Dietary supplements Bottled water Food additives Infant formulasCosmetics:Color additives found in makeup and other personal care productsSkin moisturizers and cleansersNail polish and perfumeWe can -Create FDA compliant supplement and nutritional fact sheetsReview your labeling and advertising material for compliance with the FDAReview of additives and ingredients used in cosmetics