Medical Device Qualified Supplier Directory
Benchmark Electronics, Inc. Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
Corporate Headquarters: Scottsdale, AZ
NYSE Symbol: BHE
Benchmark Electronics is an FDA-registered contract manufacturer of Class II and Class III medical products and is the Manufacturer of Record for many final devices. As a spin-off from a Medical Product Company, Benchmark has been a leader in this industry since 1979. A global footprint of ISO 13485 certified facilities provide our customers with regional PCB build, system level assembly and sourcing at a competitive price in the United States, Mexico, Europe and Asia.
Being a top-10 EMS provider of integrated electronics manufacturing, design and engineering services, our world-wide network of state-of-the-art facilities provides a stable and low-risk “launching pad” for the creation and production of advanced electronics-based products.
Key differentiators of Benchmark Electronics include:
- A market-focused approach leveraging optimized core competencies
- Full service design through supply chain, prototype, test, validation & launch
- Precision mechanical services through our Precision Technologies divisions
- A streamlined phased development process
- Global, integrated, advanced quality systems and tools
- Configure to Order (CTO) & Direct Order Fulfillment (DOF) Solutions
- All services “under one roof”
Offering a full range of services, including comprehensive product design and engineering capabilities, Benchmark provides complete turn-key solutions for our customers around the world, all “under one roof.” Services include engineering design for RF/Wireless. Benchmark has a long history of designing and replicating custom Automated Assembly and Test Systems. We also have a global network of Precision Technologies service centers providing the latest in precision mechanical manufacturing. No project is too difficult or complex – we prefer a challenge and have the engineering expertise and advanced technology to shorten your time-to-profit.
All of our engineering and manufacturing services are available in strategically placed LCR (Low Cost Region) facilities around the world.
Our full life cycle QSR compliant and ISO 13485 certified processes begin with medical product design & development, supply chain development, prototypes, test development, validation, product launch, sustaining and support of medical products, including fulfillment services, through end-of-life. Our phase gate approach with key milestones, state-of-the-art tools and regulatory experience help ensure that strict requirements for FDA and CE marking are met while achieving product innovation, quality and end-customer satisfaction.
Benchmark’s Quality Systems and Integrated Quality Tools are best-in-class for launching, tracking, monitoring, trending and controlling materials, manufacturing and test solutions. Benchmark’s internally developed Process Feedback Systems is an innovative, robust tool that provides full control down to the batch lot / date code level on products and their materials. Web based portals enable our customers to obtain real-time access to this data. By having internal control and configuration of these tools, Benchmark is able to offer our customers the next level of flexibility and adaptability in their manufacturing solution.
- ISO 13485: 2003
- ISO 14001: 2004
- ISO 9001: 2008
- Japan: Revised Pharmaceutical Affairs Law (RPAL)
- FDA Registered – Manufacturer of Record
- Compliant with FDA Quality System Regulations (21 CFR Part 820)
- Compliant with FDA Electronic Records & Signatures (21 CFR Part 11)