Engineering Safe Reliable and Connected Medical Devices
Infusion & Drug Delivery systems |
Diabetes care & Insulin Delivery |
Surgical Systems |
Orthopaedics: Spine, Hip, Knee & Shoulder |
Hospital Equipment & ICU beds |
Cardiovascular & Endovascular |
Electro – Mechanical & Sterile packaging |
Power Tools |
Patient Monitoring |
Product Design & Engineering
New Product Development | Product Concept/ Feasibility/ Spec Design & Development, Design Verification & Validation, Design Review, Design Transfer |
Sustenance & Post Market | Defect Management, Value Engineering, Localization, Shelf Life Studies, ISO Testing, Legacy Conversion, Obsolesence Management, ECM, PMS |
Remediation | DHF & RMF, Translation Services, CAPA Initiatives, UDI, Acquisition Remediation, FDA483, Technical Publications |
Regulatory | 21 CFR, IEC 62304, IEC – 60601 & particular standards |
Standards | ISO 13485, ISO 14971, IEC 60601, IEC 62304 |
Mechanical Engineering Capabilities
Design | DFM, DFx, Industrial Design, 3D & Analytical Modelling, Design Automation |
FEA | Linear & Nonlinear, Dynamic Analysis, Thermal & CFD: Thermo-Mechanical Analysis, Cumulative Damage Analysis, Snap Fit Analysis |
Reliability & Analysis | Reliability Allocation & Prediction, Hazard Analysis, FTA, FMEA/ FMECA |
Manufacturing Engineering | Digital Manufacturing, PCM Layout, Tool Design – Plastics, Sheet Metal, Casting, Manufacturing Eco System, Should Costing |
Embedded & Electronics Capabilities
Software Development | Software Design, S/W & H/W Integration, Device Mobility/ App Development |
Hardware & Firmware Development | Low level drivers, Boot loader, RTOS, System Integration, Model Based Development |
V&V and Testing | Functional, Unit and Integration Testing, Test Script and Protocol, EMI/ EMC Testing, Black Box/ White Box |
Programming | C, C++, Matlab, AVA, Python, .Net, Labview |
Protocols | SPI, CAN, UART, RS232, I2C |
OS | QNX, LINUX, Windows, iOS, Android |
Connectivity | Bluetooth, BLE, WiFi, Zigbee, RF |
DSP | Image Processing, Audio Processing, ECG, EEG |
Digitization
Shop Floor Automation
Smart Process Automation
Manufacturing Intelligence
IOT
Augmented and Virtual
Embedded Solutions
Mechanical Engineering
Technical Publication