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ISO 13485

Established in 1978, DPMS has established itself as a premier ISO 13485 manufacturing company that can manufacture ISO 13485 medical devices. This is not only evident in the San Francisco Bay area, but as our customer base shows, throughout the world.

Over the years, DPMS has developed many core and specialty services. Many of these services were designed to support our ISO 13485 customers and successfully manufacture their ISO 13485 medical devices.

Part of our core services, is our CNC Machining department. This department has grown to include multiple CNC Horizontal and Vertical Mills with Pallet Systems, 5 Axis Machining, CNC Lathes with Live Tooling, Screw Machining, Wire & Sinker EDMs and precision Grinding. These services, as you may know, are the backbone of any successful ISO 13485 medical devices manufacturer.

As a leading Bay Area manufacturing vendor with the ISO 13485 certification, DPMS utilizes a team of career Machinist, experienced Programmers, a robust Quality System with qualified Personnel, dedicated Program Managers and skilled Engineers to support our customer’s diverse manufacturing needs.

Being an effective ISO 13485 medical devices manufacturer takes a team effort. As mentioned above, our manufacturing team is supported by a robust quality system that is certified to the following standards:

  • ISO 13485
  • AS9100
  • ISO 9001
  • ITAR compliant

As you may know, an important benefit of these standards, is the ability for DPMS to provide complete “bumper to bumper” traceability on all aspects of your projects. This is especially important in the ISO 13485 medical devices field where robust quality systems are required.

DPMS introduced an MRP system in 2009 to help manage all aspects of our business. This system is also beneficial for our customers that require ISO 13485 certification since it records all aspects of the manufacturing and quality processes used on their ISO 13485 medical devices and assemblies.

Our Quality Management System is ISO 13485 certified and supports customers who manufacture medical devices. Since earning the ISO 13485 medical device registration, companies have partnered with DPMS to support their manufacturing needs.

We invite you and your team to visit our facility, view our manufacturing department and realize the full capabilities of DPMS.

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