The Highest Quality of Manufacturing
For over 30 years we have provided design and manufacturing services and implemented stringent quality processes that have resulted in the most reliable products on the market, earning us the respect of the medical device industry’s most demanding customers.
At Electrochem, we adhere to the highest standards that ensure the best in quality and reliability, including the following:
- ISO9001:2008 certified
- ISO13485:2003 certified
- ISO14871 risk management practices
- Corrective / preventive action processes
- Product / process qualifications
- UL compliance
- Lean and six sigma processes
- Product serialization with traceability to specific manufacturing day, line and cell lot
- Eagle Eye – a zero-defect quality and safety program
- Highly skilled and seasoned production personnel with extensive experience in the design of medical batteries and chargers for the healthcare industry
- A robust supply chain that includes qualified cell manufacturers who are approved for use in critical battery pack designs
- State-of-the-art, 82,000-sq. ft. manufacturing facility
- Maintaining one of the lowest Defects Per Million (DPM) rates in the entire portable power industry (less than 600 DPM)
- Process Failure Mode and Effect Analysis (PFMEA) of the manufacturing process
- Design Failure Mode and Effect Analysis (DFMEA)
- Identification and traceability is established by the manufacturing order and is maintained for each product order, recording, assembly, inspection, and test steps enabling Electrochem to track and pinpoint the affected product (unfinished or finished product) within and outside our manufacturing facility
- Build in quality with next step inspection, final production tests & sign-offs on each production run -Generation and maintenance of Design History Files (DHF), and Device History Records (DHR). DHFs include any records which describe the design history of a device — design review notes, verification plan and results, validation plan and results, FMEA results. DHRs include documentation affiliated with production — test reports, test data, signed build documents, Certificate of Compliance (CoC), and quality assurance checklist
Superior Supply Chain Management
As a subsidiary of Greatbatch, Inc., Electrochem has significant purchasing power which allows us to drive tremendous efficiencies into the supply chain. This benefits our customers in the following ways:
- Minimizes production risks due to material shortages
- Ensures superior material used in the production process
- Volume purchasing translates into competitive material pricing
- Kanban options provide customers with the flexibly and responsiveness they require
Live: Watch Electrochem in the ER
Portable Medical Capabilities Brochure: Available for download
Product Solutions: Learn more about our pack capabilities
Technical Datasheets: Available for download
MSDS Documents: Available for download
Battery Academy: Learn key industry facts
