A B. Tech Mechanical Engineer offering 6 years of product-development & designing solutions in Medical Devices products. Notable Clients for which product development-engineering services were offered are Covidien, Boston Scientifics Inc., American Medical Systems, Endo-Healthcare, Hospira, Cook Medicals, Johnson & Johnson (J&J). I've extensive experience in design control, DHF remediation, design verification & validation testing and Tech File remediation. Also I've worked on many Regulatory submission projects for US & EU submission. Extensive knowledge of standards ISO 13484, ISO 14971, ISO 10993-1, EN ISO 15223-1 & EN 1041.