Inteprod
Inteprod LLC is a pioneer in the creation and manufacturing of medical and life science devices, committed to delivering superior quality and innovative contract manufacturing solutions that bring complex products to life. Since 2004, they have been supporting leading producers and emerging innovators in the medical device, MedTech, and diagnostic industries, focusing on quality, reliability, and speed to market. They are ISO 13485:2016 certified and FDA registered, with extensive experience in manufacturing complex, high-performance medical devices and diagnostics. Their services span the entire product lifecycle, including design, development, manufacturing, quality assurance, and post-production support, emphasizing quality and regulatory compliance. They have a proven track record of zero findings in multiple ISO audits, underscoring their commitment to excellence.
Industries
Nr. of Employees
small (1-50)
Inteprod
Products
Handheld cranial scanning device (OEM manufactured)
Contract-manufactured handheld medical device that uses near-infrared spectroscopy to detect intracranial hematomas; includes molded housing and docking station, assembly, testing, and DHR control.
ISO 13485:2016 Certified Contract Manufacturer & FDA Registered
Inteprod provides ISO 13485:2016 certified contract manufacturing and regulatory compliance services for medical devices, medical diagnostics, and disposables.
Product Contract Manufacturing
Full service contract manufacturing for devices and diagnostic products, covering technology transfer, design for manufacturing, quality assurance, supply chain management, complete product assembly, packaging, and delivery.
Contract Manufacturing Services for Medical and Life Sciences Technologies
Full life cycle development and contract manufacturing services for medical and life sciences technologies, managed through a robust Quality Management System.
Process Qualification & Line Validation
Support for IQ/OQ/PQ protocols and risk-based validations to confirm process reliability and product quality.
Alpha, Beta & Pilot Builds
Executes early production runs including alpha and beta builds to validate manufacturing processes and product performance.
Handheld cranial scanning device (OEM manufactured)
Contract-manufactured handheld medical device that uses near-infrared spectroscopy to detect intracranial hematomas; includes molded housing and docking station, assembly, testing, and DHR control.
ISO 13485:2016 Certified Contract Manufacturer & FDA Registered
Inteprod provides ISO 13485:2016 certified contract manufacturing and regulatory compliance services for medical devices, medical diagnostics, and disposables.
Product Contract Manufacturing
Full service contract manufacturing for devices and diagnostic products, covering technology transfer, design for manufacturing, quality assurance, supply chain management, complete product assembly, packaging, and delivery.
Contract Manufacturing Services for Medical and Life Sciences Technologies
Full life cycle development and contract manufacturing services for medical and life sciences technologies, managed through a robust Quality Management System.
Process Qualification & Line Validation
Support for IQ/OQ/PQ protocols and risk-based validations to confirm process reliability and product quality.
Alpha, Beta & Pilot Builds
Executes early production runs including alpha and beta builds to validate manufacturing processes and product performance.
Services
End-to-end manufacturing services including technology transfer, transfer-to-manufacturing, design for manufacturing support, supply chain management, assembly, final test, packaging, and shipment to end user.
Manufacture of diagnostic instruments and consumables including handheld/point-of-care devices, lab-on-chip products, analytical instruments, and pathogen detection consumables.
Design for Manufacturing, part design, CAD modeling, rapid prototyping, product/process validation, and sustaining engineering support to optimize manufacturability and cost.
Quality management and regulatory support including document control, DMR/DHR management, process control, CAPA, deviation handling, and audit support.
End-to-end manufacturing services including technology transfer, transfer-to-manufacturing, design for manufacturing support, supply chain management, assembly, final test, packaging, and shipment to end user.
Manufacture of diagnostic instruments and consumables including handheld/point-of-care devices, lab-on-chip products, analytical instruments, and pathogen detection consumables.
Design for Manufacturing, part design, CAD modeling, rapid prototyping, product/process validation, and sustaining engineering support to optimize manufacturability and cost.
Quality management and regulatory support including document control, DMR/DHR management, process control, CAPA, deviation handling, and audit support.
Expertise Areas
- Contract manufacturing (medical devices and diagnostics)
- Quality management and regulatory compliance (ISO 13485, FDA QSR)
- Technology transfer and production scale-up
- Electromechanical device design and assembly
Key Technologies
- Injection molding and tooling
- Rapid prototyping (3D printing/3D imaging)
- CAD (SolidWorks)
- Lab-on-chip microfluidics
News & Updates
Inteprod manufactured a life-saving device that detects traumatic brain injuries using infrared spectroscopy. This handheld device scans TBI patients onsite with high accuracy, helping to save lives through early detection.
Inteprod has achieved ISO 13485:2016 recertification with zero findings for the 11th year in a row, demonstrating their unwavering commitment to quality, reliability, and excellence in medical product manufacturing.
Inteprod's consistent record of zero findings in ISO 13485:2016 audits underscores their commitment to quality, reliability, and excellence in medical manufacturing.
Inteprod manufactured a life-saving device that detects traumatic brain injuries using infrared spectroscopy. This handheld device scans TBI patients onsite with high accuracy, helping to save lives through early detection.
Inteprod has achieved ISO 13485:2016 recertification with zero findings for the 11th year in a row, demonstrating their unwavering commitment to quality, reliability, and excellence in medical product manufacturing.
Inteprod's consistent record of zero findings in ISO 13485:2016 audits underscores their commitment to quality, reliability, and excellence in medical manufacturing.