Medical Device Qualified Supplier Directory
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
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 1986. Our 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)
- Pacemaker Equipment
- Image Scanning Equipment
- Award-winning PDA and cellphone for the blind
- Cardiac Imaging Equipment
- Infrared Sensing and Image Projection
- Infusion Pumps
- Patient Monitoring Equipment
- Anesthesia Equipment
- Cardiac Defibrillators (AED’s)
- Audiology Screening and Diagnostics
- Award-winning integrated cycler
- Neurostimulation Devices
- Trans-cranial Doppler Systems
- ICD Design
- Clinical Glucose Meters
- Home-use glucose meters
- Award-winning Vein Finder
- Mobile X-ray
- Negative pressure Wound management
- Sleep Apnea monitors
- Infant Hearing testing and monitoring
- Genetic analysis
- Award-winning Mass Spectrometer
Key Medical Elements
- Requirements management and tracking
- Requirements traceability through Verification and Validation testing
- Independent, peer design reviews
- Risk management
- Reliability Analysis
- Design History Files managed in Agile
- Management of Clinical Studies
- Component engineering (Obsolescence and EOL management)
- Industrial Design
- Doctor and Patient focus teams
- Ergonomics Studies
- Software Coding standards, guidelines and control
- Experienced Medical Software development monitored by software quality staff
- Extensive software, tools and development environment with version control
- CPU Architect
- Custom motherboards
- BIOS development
- Touch Screen
- Reference Design Platforms available
- User interface
- RF / Wireless Design
- Medical mixed bands
- Medical low frequency
- Inductive communication
Benchmark Electronics is proud to have received numerous awards from medical industry groups, including:
- Medical Design Excellence Awards
- International Forum Design Award
- GSMA Awards
- Swift Award
- Industrial Design Excellence Awards
- A' Design Award
For more information contact Benchmark Electronics
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Angleton, TX United States
3000 Technology Dr.
Arden Hills, MN United States
Northpark Corporate Ctr., Ste. 200
Arden Hills, MN
New Hampshire Division
100 Innovative Way
Nashua, New Hampshire
3535 Technology Drive NW
San Jose, CA
5550 Hellyer Ave.
San Jose, CA
Winona, MN United States
4065 Theurer Blvd.