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iLenSys Your Reliable Partner In Design And Engineering Support • End to End engineering solutions for entire life-cycle of projects • Improve time to design solution in a competitive market • Consistent, quality design solutions within budget Medical Equipment & Devices www.ilensys.com • Industrial Design per FDA draft guidelines for usability • CAD Design/Development to Large scale Ramp up Support • Risk & Regulatory compliance Management • IP Assessment (Patentability , FTO) • Product Optimization / Sustenance Engineering, VA/VE • Electrical and Electronics Engineering • Technical Writing and Documentation • Firmware and Embedded Software Engineering • Wide Range of Medical Domain Expertise • Ideation, Detail Design, BOM, Tol Stack up, Proportion parts, simulation (FEA), DFX, DFA, DFM • Design Verification Plan (DVP) Creation, Design Freeze Manufacturing of prototypes, Execution of DVP on prototypes • Developing Test Protocols, SOA (sequence of Assembly) • "DHF" versioning of all required documents, design report at end of stage • Expertise in Regulatory Compliance ISO 13485:2003, 14971, 10993, FDA 21 CFR 820.30, IEC 60601, USFDA, EUFDA • Lab Equipment’s • Monitoring and Diagnostics • Implants and Prosthetics • Therapeutic Devices • Respiratory Devices • Ophthalmic & Drug Delivery System • Rigid Pharma & Medical Device Packaging DOMAIN EXPERTISE SERVICES STRENGTHS NPI (NEW PRODUCT INTRODUCTION) • Complete Ownership of product Design life cycle as per the Regulated guidelines of FDA 21 CFR 820.30 Design Controls UX/GUI DESIGN • Redefining User Interaction with responsive and intuitive • Designs on par with smart phones the Next Gen Experience SUSTENANCE ENGINEERING • A cost-effective, efficient and responsive product sustenance engineering practice to leverage global technological advancements INDUSTRIAL DESIGN • Persistent to translate Voice of Customer to Innovative product design ELECTRICAL & ELECTRONICS • Expertise in System integration, Hardware and software development • Firmware and Embedded Software Engineering DIGITAL SERVICES • Technical Publications, Virtual Reality for Trade-Shows, Digital Work Instructions
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