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Medical Electronics Manufacturing

Risk Mitigation For Leading Edge Medical Devices

Designing and building innovative life-sustaining devices comes with high levels of risk. With our long-standing commitment to quality and service, Vanguard EMS can help you mitigate risk and build defect-free products that get delivered to your customers on time.

FDA Manufacturer of Record

Vanguard EMS is the FDA manufacturer of record for four system-level Class II and Class III devices, including pneumatic and electro-mechanical products.

Our test and inspection strategies catch defects in real time, saving you time and money. Any defects are remedied before the product can move to the next step of the manufacturing process. Our Failure Reporting and Corrective Action System (FRACAS) integrates corrective action hosting, status, and disposition with our SMARTer Manufacturing™ system. As a result, we are able to seamlessly perform detailed root cause analysis on reported issues, and implement resolutions in a timely manner.

We produce interactive work instructions that take all guesswork out of assembly, and our highly qualified technicians can only work on your product once they have been trained to your requirements.

We provide full traceability for every medical device we make. You’ll have records of every tool, piece of equipment, team member, and training record that touched each device. In the unlikely event of a device failure due to a manufacturing or component defect, you’ll be able to quickly see your product’s entire manufacturing history to help diagnose the problem.

You can trust that Vanguard EMS takes quality and reliability very seriously.

First Class Capabilities

Vanguard EMS continues to invest in leading-edge manufacturing capabilities.

Our ViTrox Advanced 3D X-Ray Inspection (AXI) tool examines PCBs at the micron level to catch defects other processes might miss. Our 12-zone reflow oven provides granular control over solder uniformity and reflow profiles, ensuring electrical consistency across PCBs while maintaining low production times.

When your company’s reputation is on the line, you can be confident that your products have been built and tested to exacting standards.

Who We Serve

• You need to manufacture Class II or Class III medical devices.

• Traceability is really important to you, and you need your manufacturer to provide full traceability and documentation.

• Teams facing complex assembly challenges.

• You’re looking for Tier 1 capabilities, but with flexibility and focus.

• Companies that want to get their product to market quickly.

• You need an attentive program management team to efficiently guide your product through prototyping, new product introduction, manufacturing and manage through the product life cycle.

• Your EMS has to provide the same focus, sense of urgency, and attention to detail you give your own products (that you won’t get from a larger manufacturer).

• Product demand is variable, and you need flexibility in meeting it.

• Your supply chain needs simplification, repatriation, or diversification.

• You need a manufacturer who aligns multiple supply chain strategies to guarantee for upside to your forecast and protect against downside.


• Multiple build levels:

• Sub-level: Partial electrical and/or mechanical assemblies.

• Box build: Multiple sub-level assemblies wired together.

• System-level: Final product built and tested to regulatory requirements. Includes manuals, final packaging, and any branding requirements.

• Power:

• 3D X-Ray and CSCAN analysis of void areas, and mitigation with 12-zone nitrogen reflow.

• IPC Class 3 solder joint compliance on thick substrates with significant copper.

• RF:

• Assembly and test of complex RF systems with multiple PCBAs.

• Speeds up to 18 GHz.

• Real time detection and avoidance of defects that affect signal integrity, including tin whiskers, billboarding, and tombstoning.

• Component tolerance stack up root cause analysis.

• Real-time collaborative review of test results: trends, drifts, frequency performance.

• Shielding.

SMARTer Manufacturing Keeps You In Control

SMARTer Manufacturing™ is our proprietary process flow and manufacturing execution system, designed and refined specifically for electronics manufacturing for over 12 years to provide you an extremely high degree of robust information, tracking and holistic quality control.

Rapid Manufacturing Feedback

SMARTer Manufacturing™ provides you near real-time quality measurement and tracking information, from the initial order of goods through production and testing. With the following information available to you, you’ll have clear insight into your product as it progresses through the manufacturing process:

• Detailed data to the sub-component level to assist efficient decision making for product improvements.

• Test trends and drifts for collaborative review.

• Near real-time quality measurement and tracking to aid FRACAS if a problem arises.

Zero Tolerance for Risk

SMARTer Manufacturing™ is designed to substantially limit risks in complex manufacturing processes:

• Technicians are always trained to the latest standards. SMARTer does not allow work on a product if a technician has not been trained to all relevant requirements.

• Technicians cannot bring up electronic work instructions if they failed their ESD test.

• SMARTer produces a highly detailed device history record, down to the component level. Every piece of equipment, every tool, and every team member (and their training records) is recorded.

• Defects are stopped before moving on to the next manufacturing step.


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