Medical Device Contract Manufacturing
We provide medical device contract manufacturing solutions to global MedTech companies as well as innovative start-ups. Our facility is equipped with advanced capabilities to manufacture complex to high-volume products. The core manufacturing services include Electronics PCB Assembly, Mechanical Assembly, System Integration, Quality Testing as per ISO 13485 and US FDA Standards, Labelling, Packaging and a global Supply Chain. With access to Class 100,000 clean room, Surface Mount Technology (SMT), Automatic Optical Inspection (AOI), 3D Printing and Cable harness fabrication, we ensure cost-optimized, regulatory compliant and time-bound manufacturing for our clients.
Design for Manufacturing
Our DFM support helps you get the best out of your product on various parameters including efficiency, size, complexity, customization and recurring costs. We ensure early identification of opportunities and unpredicted challenges in the manufacturing process. It helps you maximize profitability, accelerates your go-to-market and safeguards you against late discovery of design issues which might impact full scale production.
Sourcing and Procurement
We maintain a strong bench of vendors and can therefore scale up our manufacturing capacity at any point of time. We ensure:
- SAP based record maintenance
- Climate controlled warehousing
- Shelf-life management of components
- 400+ registered vendors
Our comprehensive and stringent project management enables us to add value at every stage of the manufacturing process:
- Combining advanced manufacturing techniques with Lean manufacturing principles
- Safeguarding documentation to ensure control over raw materials
- Cost Optimization
Launching a new product entails multiple risks. It’s crucial to make a pilot run for testing the line and ironing of kinks. The process is necessary to set pace and accuracy during new product mass production.
PCB Assembly & SMT
Our state-of-art manufacturing facility is equipped with robust capabilities to facilitate efficient manufacturing with zero errors. We continually enhance our processes for PCB assembly and functional testing to create next generation medical devices.
Automated Environment To Maximize Productivity
We focus on automation to integrate our equipment, people and processes—improving productivity, quality, responsiveness and accuracy of decision making throughout the product lifecycle.
Automatic SMT Pick & Place
The automatic SMT Pick & Place machine multiplies production four-folds by the capacity of 32000 CPH/ hour. The accuracy is up to 12 microns and the time involved is halved.
3D - Optical Automation
AOI has an Integrated Electronic Test strategy to ensure fast and zero error inspection. The machine inspects PCB with high definition camera for scratches, nodules, stains, dimensional defects, and misplaced components.
PCB Production Capabilities
We produce multiple types of PCB – Flexible, Rigid, Backplanes, and Multilayer. Quick turn prototyping and RoHS compliant PCB production by IPC certified technicians. Our PCB capabilities include:
- 01005 Components placing
- Mount Flip Chip, BGA, MELF,CSP
- PCB Size up to 500mm x 450mm
- Single & Double-sided PCB
- Automated placement capacity,32000 CPH
- Fine Pitch components up to 20mil
- High Density Interconnects (HDI)
- RF microelectronics
- Chip on board
Our PCB Testing involves checking assembled PCB for effectiveness in the end-user environment. We streamline our testing in several steps to evaluate and confirm overall efficiency. Major tasks performed during PCB testing are:
- Functional Testing
- 3D AOI (Automatic Optical Inspection)
- Solder paste inspection
- Customized PCB programming test
- In circuit test
Full assembly services from PCBA to final integration. We have multiple assembly lines enabling simultaneous integration of simple to complex electronic medical devices.
High Volume Production
Our advanced manufacturing capabilities
and strategically planned assembly lines
enable the production of
6000 Handheld devices per month.
What goes behind the scenes truly sets us apart!
As one of the top Medical device contract manufacturing company, we have comprehensive project management system, enabling us to add value at every stage of the manufacturing process. We combine advanced manufacturing techniques with Lean six sigma protocols for quality output.
Our streamlined change management process ensures that we cater to the requirement of any on-going changes to address Customer Complaint, Market Feedback, Product Enhancement and Cost Improvement.
We readily address and record changes required in the product at pre and post-market stages. Our documentation process, including ECR (Engineer Change Requirement document) and ECN (Engineer Change Note), is strictly maintained to track every big and small change at every step. The documentation process assures traceability over years.
Quality Control at every step
We perform various tests on products or batches of products to assure confirmation of product specifications. Our comprehensive Quality Control processes are segmented into three stages IQC, IPQC and FQC.
- Raw material testing
- Regular equipment testing
- Technician training & development
- Isolating Non- Confirming Products
- Product Testing
- Corrective & Preventive Action (CAPA) management
Supply Chain Management
The SAP enabled warehousing ensures highest degree of traceability of components.
We continually monitor and evaluate our suppliers for their compliance to meet the quality standards for procured parts. We perform:
We work closely with a robust network of international logistic partners to ensure: