Introduction
At EmSyS, 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, EmSyS 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:
- Meet International Regulatory requirements
- Reduce time-to-market
- Achieve Price Competitiveness
- Address Market Dynamics
- Stay ahead of the Competition
We have experience in developing
- Patient Monitoring System
- Ultrasound Scanner
- The Central Nursing Station (CNS) for ICU / ICCU
- Electro Surgical Equipment
- PC Compatible Motherboard design for Ultrasound Scanners
- Advanced Modular Patient Monitoring System
- Medical Ultrasound Image Processing
- Blood Mixer
- Home Care through Dial-up Networking
- DICOM Compatible Diagnostic Ultrasound
- Ultrasound based Bone Densitometry
Our Service Offerings
End –to– End Service Offerings
- Capturing Voice of Customer (VOC)
- VOC to Engineering Requirement Specification
- Industrial Design
- Product Conceptualization
- Design & Development
- Prototyping
- Product Integration & Testing
- Verification & Validation
- Risk & Hazard analysis
- Regulatory Compliance & Product Certification
- Design Transfer for Manufacturing
- Maintenance / Sustenance Engineering
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
- Other Services
- Porting / Re-engineering to new platforms, Sustenance Engineering, Value Engineering,
Obsolescence Management, RoHS Compliance, Product Life Cycle Management
Regulatory Compliance and Certification Services
- EmSyS 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