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| Medical Devices |
| At EZEN ES, we understand that in the medical device industry, relevant experience is of pre-eminent importance to address key design issues and surmount outsourcing challenges. With more than 20 years of medical product design and development expertise, ES surges ahead in medical domain, providing cutting edge solutions to some of the best known names in the industry. Our solutions have helped customers to:
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- Accelerate R&D Throughput
- Reduce Costs both in R&D and Operations
- Increase Market Share
- Increase Revenues and Profits
- Meet International Regulatory requirements
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| End-to-End Service Offerings |
- Capturing Voice of Customer (VOC)
- VOC to Engineering Requirement Specification
- Industrial Design
- Product Conceptualization
- New Product Design & Development
- Prototyping
- Product Integration & Testing
- Design Verification & Validation
- Risk & Hazard analysis
- Regulatory Compliance & Product Certification
- Design Transfer for Manufacturing
- Product Localization
- Active Product Support & Sustaining Engineering
- Packaging and Labeling
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| Embedded Design Services |
- Embedded Software Development
- Kernel, Drivers, BSPs & Application on RTOS / Custom Kernel Systems
- Embedded Hardware Development
- uP / DSP / FPGA / Analog & Mixed Signal
- Verification & Validation
- HW / SW Verification, Validation, Hazard analysis (as per medical device directive)
- Medical Regulatory Compliance
- AAMI, IEC, UL, CSA, CB
- Support in CE Marking, USFDA approval (510K), SFDA, CMDCAS In-house
- EMI / EMC Test facility (Third Party Partnership)
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| Other Services |
- Porting / Re-engineering to new platforms,
- Sustenance Engineering, Value Engineering, Obsolescence Management,
- RoHS Compliance, Product Life Cycle Management
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| Regulatory Compliance and Certification Services |
- ES can support with necessary test reports and documentation for complying with certifications / approvals for CE and FDA
- In-house setups for RE & CE Tests, RS Test, Environmental Tests, Vibration Tests, Shock & Bump Tests, EFT, Surge, Electro-static Discharge (ESD)
- Hazard Analysis :
In line with EN 60601-1-4 & EN 1441 and ISO14971 that takes into account:
- Hazardous Events
- Level of concern of the Hazard
- Cause(s) of the Hazards and Control Mechanism
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| Technology Experience |
We have done extensive work in the following domains for Medical Devices
Physiological Signal Acquisition and Processing
- Signal Noise Elimination Algorithms
- Imaging Algorithms
- Graphical User Interface Design
- Wireless Communication
- Device Networking
- Motion Control
- Analog Design
- High-speed Digital Design
- Power Electronics
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| Technology Skills |
- Software
- Dialog-based, Single Document Interface (SDI) and Multiple Document Interface (MDI) applications
- ActiveX Controls
- Dynamic Linked Libraries (DLL)
- Data Acquisition Software
- OS : DOS, Win 2000 / XP / Vista
- RTOS : Win CE, VxWorks, µCLinux
- Languages: VC++, C++
- Windows Driver Development
- Jungo WinDriver
- Hardware
- Actel FPGAs
- Xilinx FPGA
- Analog Devices ADSP, TI DSP
- Freescale PPC
- 8 / 16 Bit Microcontroller
- Cypress USB2.0 Controller
- X86 Geode Motherboard
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| CAD/CAM/CAE TOOLS |
- PLM: Windchill, TeamCenter, SAP-PLM, Enovia , ADAPTIVE
- CAD: AutoCAD, Pro-E Wildfire, Solid Works, Ideas NX, UG NX, Solid Edge, Catia
- CAM: Catia, UG NX, Tebis, Delcam, SurfCam
- CAE / CFD: Hypermesh, Ansys, Abaqus, Nastran, LS Dyna, Star CCM+, Fluent
- RE: Alias, Icem, Catia, Imageware
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