Medical Device Contract Manufacturing Services

ISO 13485 certified and FDA registered company in USA

We have been a contract manufacturer in medical device contract manufacturing industry around 15 years. Medical device manufacturing is the biggest segment we are serving. We have rigid process abd well experienced professionals in managing the full compliance in accordance with medical industry regulatory requirements.

For most of the cases, the medical device contract manufacturing is high-mix low-volume in nature. It requires adequate and skillful resource to carefully manage it. We have built a solid infrastructure, a Manufacturing Execution System (MES) and a competent team to support the complexity and dynamic nature of the medical device contract manufacturing requirements.

With our continued commitment in high mix manufacturing, we have been well recognized as the vendor of choice by our customers, especially the medical device customers. Quality, Speed, Responsiveness and Consistency are our specialty. We are a reliable partner you can always count on.

P2-Medical Device Contract Manufacturing

Best in Class Services

We offer best in class Medical Device Contract Manufacturing Services to leading and also new start-up medical equipments OEM companies. We provide complete manufacturing services from PCB board assembly, box-build, testing & fulfillment services. For material sourcing and management services, we provide turnkey, consignment, and hybrid material solutions per customer requirements. We have earned great repuation through our high quality, on time delivery and responsive services.

Manufacturing Execution System (MES)

Sparqtron produces superior medical devices and equipments by implementing an integrated Manufacturing Execution System (MES). This MES software system along with the real time barcode data collection devices strengthens our quality control, and manages documentation for traceability and regulatory compliance. We can tailor the traceability system based on customer requirements.

Maintaining Medical Device History Records

Sparqtron maintains medical device history records (DHR) in accordance with the requirements of the FDA regulations. Sparqtron Quality System ensures that DHR's are maintained in accordance with the Device Master Record (DMR).

Well planned & attention to details

Your project will be in good hand with us. Our proactive planning and attention to details, along with comprehensive engineering support and superior manufacturing technology help medical equipment customers quickly build quality prototype and NPI (New Product Introduction) on schedule. Significantly speed up the "Time-to-Market" for you.

Do it right the first time

We offer pre-DFM to help customer's design engineers to correct any design issue before finalize their design for prototype build, our attention to details and our value-added engineering and manufacturing expertise help customers to do it right at the first time. We also provide post-DFM to further minimize any manufacturability issue for future volume production builds.

Leverage our buying power

Our component engineer helps customer find alternative parts to solve lead time problem and also helps material cost down. Our Far East procurement team can further help sourcing materials form Asian suppliers for cost reduction.

The Best of Both Worlds (Speed & Cost):

Local: USA - to speed up your "Time-to-Market"

Sparqtron provides responsive local quick-turn prototyping, NPI services and low-to-medium production, helps you achieve faster "Time-to-Market".

Off-shore: Far East – for “Cost Down” and gain "Market Share"

When your volume achieves high volume, we help you move production to lower cost Far East manufacturing facilities, help you being more price competitive and increase your "Market Share".