Engineering Safe Reliable and Connected Medical Devices
Integrated solutions offering across engineering, manufacturing and supply chain
Efficient delivery process and quality procedures for regulatory and safety compliance
Strong program management practices and capability in terms of technology and scalability
Flexible engagement and cost models for offshore and onsite development
Reliable eco system for sourcing, prototyping and manufacturing| 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 |
Readiness to invest based on ROI
Risk reward sharing partner
Rapid resource augmentation
On time regulatory compliance
Rapid Adoption to new tech
Lower development cost
Faster time to market
8+ years of experience in Medical Device Engineering Services
Partnered with one of the Top 5 orthopaedic customers to implement UDI faster
Strong expertise in Mechanical Design, Embedded Electronics and Value Engineering
Strong understanding of FDA 510(k), ISO 13485, ISO 14971 processes
Dedicated PMO office to manage cross functional projects