Hantel Technologies
Hantel Technologies is a leading contract service provider specializing in the development and manufacturing of innovative medical devices. Founded in 1999 and now a 100% Women-Owned Business, Hantel offers comprehensive services from concept to clinical, including product design, development, fabrication, testing, supply chain logistics, thermoforming, molding, and regulatory support. With over 100 years of collective medtech experience, Hantel is committed to delivering fast, flexible, and quality-driven solutions to help bring medical devices to market efficiently.
Industries
Nr. of Employees
medium (51-250)
Hantel Technologies
Hayward, California, United States, North America
Products
Laparoscopic soft-tissue ablation and cautery device (project example)
Services provided: concept development, design & development, verification/validation testing, clinical-use production, process development, continuous manufacturing, packaging, refurbishment, and regulatory submission support.
Catheter and guidewire systems (project examples)
Design, V&V, clinical-use production, process development and regulatory support for vascular access catheters and catheters with novel guidewire designs.
Oxygen saturation monitoring devices (project example)
Design and development for oral, endoscopic, cutaneous, esophageal and rectal oxygen saturation monitoring for adult and pediatric use; includes V&V, clinical-use production, process development and continuous manufacturing.
Diagnostic and test kit manufacturing (project examples)
Process development, pilot/continuous manufacturing and packaging for blood sampling test kits and viral test kits.
Personal protective equipment (PPE) development
Concept, design, verification and regulatory submission support for ASTM surgical face masks and respirators.
Medical Device Contract Manufacturing and Regulatory Services
Comprehensive quality system encompassing design, manufacturing, validation, and regulatory support including FDA 510(k) applications and ISO 13485 compliance.
Laparoscopic soft-tissue ablation and cautery device (project example)
Services provided: concept development, design & development, verification/validation testing, clinical-use production, process development, continuous manufacturing, packaging, refurbishment, and regulatory submission support.
Catheter and guidewire systems (project examples)
Design, V&V, clinical-use production, process development and regulatory support for vascular access catheters and catheters with novel guidewire designs.
Oxygen saturation monitoring devices (project example)
Design and development for oral, endoscopic, cutaneous, esophageal and rectal oxygen saturation monitoring for adult and pediatric use; includes V&V, clinical-use production, process development and continuous manufacturing.
Diagnostic and test kit manufacturing (project examples)
Process development, pilot/continuous manufacturing and packaging for blood sampling test kits and viral test kits.
Personal protective equipment (PPE) development
Concept, design, verification and regulatory submission support for ASTM surgical face masks and respirators.
Medical Device Contract Manufacturing and Regulatory Services
Comprehensive quality system encompassing design, manufacturing, validation, and regulatory support including FDA 510(k) applications and ISO 13485 compliance.
Services
Mechanical, electrical and systems integration design; design-for-manufacturing and preparation for clinical use.
Rapid prototyping and production of clinical-use units; component fabrication including catheter processes, molding, casting, welding and forming.
Development and execution of V&V protocols, human factors/usability testing, and compliance testing to ISO/IEC and other standards.
ISO 13485-aligned quality system services, FDA registration as contract manufacturer, support for IDE/IRB and 510(k) submissions, and assistance with OUS approvals.
Component purchasing, warehousing, distribution and inventory management using approved supplier networks and MRP systems.
In-house thermoforming and limited molding with integrated packaging solutions suitable for sterilizable medical devices.
Mechanical, electrical and systems integration design; design-for-manufacturing and preparation for clinical use.
Rapid prototyping and production of clinical-use units; component fabrication including catheter processes, molding, casting, welding and forming.
Development and execution of V&V protocols, human factors/usability testing, and compliance testing to ISO/IEC and other standards.
ISO 13485-aligned quality system services, FDA registration as contract manufacturer, support for IDE/IRB and 510(k) submissions, and assistance with OUS approvals.
Component purchasing, warehousing, distribution and inventory management using approved supplier networks and MRP systems.
In-house thermoforming and limited molding with integrated packaging solutions suitable for sterilizable medical devices.
Expertise Areas
- Medical device design and development
- Catheter and drug-delivery device manufacturing
- Verification and validation (V&V) for medical devices
- Human factors and usability engineering
Key Technologies
- Nitinol forming
- Ultrasonic welding
- Silicone casting
- Thermoforming
News & Updates
Exhibiting at the event from April 12–14, 2022, in Anaheim, CA.
Hantel welcomes Ron Balogh as the Vice President of Business Development.
Exhibiting at the event from April 12–14, 2022, in Anaheim, CA.
Hantel welcomes Ron Balogh as the Vice President of Business Development.