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 Veri�cation 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 • Rede�ning User

Interaction with responsive and

intuitive • Designs on par with

smart phones the Next Gen Experience

SUSTENANCE ENGINEERING• A cost-e�ective, e�cient 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