Medical Device Manufacturer in Reno, NV

Medical device companies in Reno, NV can rely on VSE for high volume lots without sacrificing quality.

At VSE, we take safety seriously, especially regarding medical devices. Not only do our products meet the high safety standards of the electronics industry, but they also comply with strict medical guidelines for patient use.

At our facility, we follow the gold standard of the electronics industry, ISO 13485, to ensure that our manufacturing processes meet the highest level of quality and safety.

Here we’ll explore our commitment to safety and quality, the technologies we use, and how we can work with you to bring your medical device ideas to life. We aim to give you the information and confidence you need to choose us as your trusted PCB medical device manufacturer in Reno, Nevada.

 

An Overview of ISO 13485 Scope
Quality Management System
  • Document quality management system and maintain effectiveness. Each underlying process will have criteria and methods for control, availability of resources and information, and diagnosable feedback for analysis.
  • Good documentation practices (including control and review of status, revisions, etc.) and record-keeping.
Management Commitment
  • Managers will effectively balance the requirements of standards with the requests of customers.
  • Adherence to quality includes a framework for objective quality review and dedicated oversight of quality processes.
Resource Management
  • A commitment to educating, training, and developing the workforce to improve quality outcomes.Follow infrastructure at the workspace, equipment, and services level.
  • Account for the health and cleanliness of personnel as well as the environment.
Product Realization
  • Establish process control, documentation, and quality objectives for the final product.Enable consistent and thorough communication with customers for accountability, improved relations, and product outcomes.
  • Tracing and measuring all inputs and outputs in product creation to minimize variance.
  • Verification and validation of product development practices.
    Tracking manufacturers’ performance and accountability for sourcing purposes.
  • Meet requirements for device installation and cleanliness, including sterilization.
  • Regular calibration and monitoring of measuring tools and equipment.
Measurement, Analysis and Improvement
  • Product needs to demonstrate conformity.Incorporate feedback to process and complaint handling.
    Schedule internal audits to check the performance and implementation of the quality management system.
  • Take action in the event of a nonconforming product (rework or disposal).
  • Keep quality management up-to-date with corrective and preventative adjustments.

The difficulty in building medical devices is not lost on our team. We understand the need for quality and high reliability regarding the devices people rely most on for health and wellness. For medical device companies in Reno, Nevada, VSE can help guide your designs through the rocky product development process with the current market challenges.

Meeting Demand for Components and Manufacturing Capacity

Continued manufacturing gaps arising from supply chain shortages have resulted in long lead times and difficulties sourcing raw materials and manufacturers capable of throughput. VSE’s new location in Reno offers solutions on both ends.

  • Shortages: Given that the medical device industry is still facing shortfalls between product supply and demand, it may come as no surprise that other shortages are raging on the market. Some components which function as fundamental building blocks of circuit design are facing extended lead times of several months, sometimes exceeding a year in length. Navigating procurement without the aid of a contract manufacturer (CM) can add unnecessary work and stress to design teams whose efforts are best concentrated elsewhere. Instead, VSE can leverage its role as a bulk purchaser to reduce per-component costs and ensure the necessary stock for production runs.
  • Capacity: As industries continue to play catch-up on device manufacturing, design teams can also face the frustration of a lack of production volume availability to meet demand. With our new high-capacity facility in Reno, VSE can offer the high throughput necessary to get medical device production up-to-speed and whittle away at backorders.

Another way VSE alleviates these issues is with dedicated supply line availability. Your design and everything related to it, such as components and materials, occupy its space separate from a central repository. You can design, and order production runs in confidence (or scale up at a later date), knowing that your assembly components are guaranteed to be available.

Summary of Common PCB Tests and Motivations

Besides manufacturing, VSE offers engineering services for component obsolescence.

VSE offers much more than manufacturing. However, with a team of engineers on-staff ready to assist teams at any stage of product development from prototyping to design for manufacturing (DFM) preparation for mass production. The component shortage has unfortunately had more knock-on effects on design, with suppliers prioritizing their most profitable chips at the expense of less cutting-edge components (but no less important to assembly). Obsolescence can delay and derail design plans as teams scramble to replace components and ensure interoperability on-the-fly. Fortunately, VSE is well-equipped to handle a fluctuating market with regular component reviews and tracking product change notice (PCN) updates. Your contract manufacturer becomes an active participant in the procurement stage, acting to get ahead of components entering end-of-life (EOL), depreciation, and high costs with a fixed supply.

Obsolescence does not only affect the bill of materials (BOM). Changes to the design forced by adapting to alternate components can significantly impact production schedules. These changes can be severe enough to require alterations to components’ form, fit, and function:

    • Form: The easiest solution for component obsolescence is an identical component in an alternate package. Incorporating a new package into the design may be a mostly seamless replacement or could require a minor revision at the board level to integrate properly into an HDI. Regardless of the level of complexity, design teams will want to ensure good data management by updating supporting files (land pattern library, schematic, etc.) before resubmitting the design for manufacturing.
    • Fit: A discontinued component can affect additional parts, like a mated connector. Replacements may also need to consider other physical aspects like thermal and electrical loading that could necessitate larger design revisions to accommodate.
    • Function: A component may differ enough from its potential replacements that the associated circuit function needs to be reevaluated. This can be especially burdensome, and depending on how integral this function is to maintaining the design intent of the product, wide-reaching changes may be required.

While it’s something no design team wants to think about, component obsolescence and availability can be extreme enough to warrant a total redesign. While this can be demoralizing, the most important thing for design teams is to keep production and DFM at the forefront. VSE can assist with this process by collaborating with teams to ensure the complete availability of the BOM.

Your Contract Manufacturer Handles All Stages of Production

Medical device companies in Reno, NV, can count on VSE as a turn-key solution from design through assembly, including wiring and cable harnesses. At VSE, we’re a team of engineers committed to building electronics for our customers across various life-saving and life-changing industries. We have the manufacturing capabilities for the mass production of your devices and for prototyping of NPIs, our San Jose location is ready to guide your design through revisions to the final product. From there, seamless integration to high-volume throughput is maintained by the same team and equipment. Whatever your PCB needs, we aim to deliver complete satisfaction for performance, reliability, and quality.

If you are looking for a CM that prides itself on its care and attention to detail to ensure that each PCB assembly is built to the highest standards, look no further than VSE. Contact us today to learn more about partnering with us for your next project.