We help global MedTech OEMs accelerate time-to-time market, mitigate regulatory risks, improve clinical outcomes and enhance patient experience through value-based partnerships with them. Our key strengths include an agile, process driven execution model, capable of managing demand variability and unlocking cost-efficiencies for our clients. As a valued partner to the medical devices industry for 10+ years, we offer services from concept to commercialization.
Our service portfolio
Product Development and Sustaining
- Design concepts to prototype solutions
- Design & development – embedded H/W & S/W, mechanical systems
- Verification & Validation
- Packaging & labeling design
- Simulation – FEA/CFD
- Sustaining engineering
- VAVE
- Technical publications
Manufacturing Engineering
- Process planning & layout design
- Plant engineering
- Process validation (IQ, PQ, OQ)
- Test fixtures design
- Controls & automation
- Supplier quality management
- Failure analysis, CAPA
- Drawings & manufacturing documentation support
Regulatory Compliance
- Regulatory submissions support – FDA, CE, other regions
- Tech file gap analysis & remediation
- MDR/IVDR transition support
- Clinical/Performance evaluation reporting
- Post-market surveillance support
- Environmental compliance – RoHS, REACH
- Regulatory packaging, labeling, IFU compliance
Digital
- IoT integration & connected products development
- Cloud enablement & DevOps support
- Data Analytics & visualization
- AI/ML
- Application development & maintenance (desktop, web, mobile)
- S/W test automation
- Product security services
