Medical Device Full Lifecycle Solution
Your One-Stop Partner from Concept to Aftermarket.
We understand how complex it can be to bring your medical device to market, and how fragmented partnerships can slow you down. That’s why we work as an extension of your team, committed to turning your idea into a market-ready product, no matter where you are in the journey.
With decades of experience and deep technological expertise, we unify every phase of medical device design, development, manufacturing, and regulatory consultation under one roof. Our integrated model and streamlined execution ensure accelerated time-to-market and lifecycle continuity for your device.
Over the years, we have collaborated with global medical device OEMs to bring to life a diverse range of diagnostic platforms, therapeutic systems, and medical aesthetic solutions, faster and cost-effectively.
Design and Development
Our design and development services are aligned with ISO 13485, IEC 62304, and FDA 21 CFR Part 820 standards. From concept to prototype, we ensure your design is innovative, regulatory-compliant, and optimized for scalable production.
- Feasibility studies, concept design, and clinical requirement mapping
- Industrial design and human factors engineering (IEC 62366)
- Electrical, mechanical (product and mold), and embedded system design
- Design for manufacturing (DFM) and design for reliability (DFR)
- Rapid prototyping and iterative risk-based validation
- Pre-compliance and compliance testing (FDA, CE, IEC 60601, ISO 10993)
- Component obsolescence management
New Product Introduction
Our New Product Introduction (NPI) team ensures design intent translates effectively into full-scale production. We formalize every aspect of the handoff through streamlined collaboration across cross-functional teams, including design engineers, supply chain specialists, regulatory and quality experts, and production personnel.
- Pilot builds with design iteration feedback
- Design transfer documentation (DHF, DMR, DHR)
- Custom test jig and fixture development
- Process validation (IQ/OQ/PQ) and documentation (FDA QSR and ISO 13485)
- DFx reviews (DFA, DFT, DFM)
- Manufacturing SOP and WI creation, operator training for production handoff, tooling assistance
Medical PCB Assembly
We stand at the forefront of delivering medical PCB assembly services that meet the stringent requirements of complex medical devices. Through automated processes, advanced testing modalities, and sustainable practices, we ensure high precision, end-to-end traceability, and compliance with global regulatory standards.
- SMT and through-hole assembly (IPC class II and III)
- ROHS-compliant processes
- Solder paste inspection, automated optical inspection (AOI), BGA X-ray inspection, and functional testing
- Automated custom test jigs and fixtures
- Moisture-sensitive handling and controlled ESD zones
- Barcode-based component level traceability and UDI integration
- Cleanroom assembly for final device integration
Contract Manufacturing
Our medical device contract manufacturing solutions are customized to meet the unique requirements of your product. With 14 ISO 13485-certified facilities and FDA-compliant processes, we support you through high-mix, low- and high-volume production. Leveraging deep technical know-how and cutting-edge technologies, we enable faster turnarounds, reduced risk, and smooth regulatory alignment across global markets.
- Medical PCB assembly, sub-assembly, system integration, and box build solutions
- Cleanroom assembly (ISO Class 7 and 8 / Class 10K and 100K)
- Laminar flow setup
- UDI labeling, serialization and lot traceability, batch control
- In-line quality checks, burn-in testing, end-of-line testing, and sterile/non-sterile packaging
- Lean manufacturing, six sigma, kaizen, and 5S implementation for efficiency and waste reduction
Supply Chain Management
We take a proactive and transparent approach to managing your device’s supply chain and ensuring uninterrupted production. Our diverse network of qualified suppliers enables timely procurement of high-quality components at optimized cost. Through component obsolescence forecasting and management, we help you mitigate risks, implement design changes, and meet market demands efficiently.
- Strategic sourcing and multi-supplier mapping
- Vendor qualification and performance audits (ISO 13485-compliant)
- Approved vendor list (AVL) management, MOQ negotiation, and inventory buffering
- Component lifecycle management and alternate sourcing for obsolete/end-of-life parts
- Import/export management and regulatory documentation (COO, FSC, BOM compliance)
- Global supplier network and logistics (air/sea/road)