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CAPABILITIES
Hantel Technologies is a fast and highly flexible contract service provider for the development and manufacturing of innovative medical devices. As full-service, high-quality, medical product experienced professionals, we offer the following services:

Product Design & Development imageProduct Design & Development
Hantel's seasoned staff of engineers and project managers can assist you in developing a broad spectrum of medical devices and life sciences instrumentation. Our leading edge medical device product development team possesses strong mechanical, electrical, and system integration skills. We leverage our capabilities to proactively integrate our proven design-to-manufacturing process.

Manufacturing imageManufacturing
Hantel's highly skilled manufacturing personnel are ready to assist with the assembly and packaging or medical products. We build in both an ISO Class 8 (100k) certified Controlled Environment and open floor manufacturing facility. We are well-equipped with a variety of manufacturing facilities. We are well-equipped with a variety of manufacturing equipment to bring medical devices to market. Our facilities and equipment are also available for private use by our clients.

Machining & Fabrication imageMachining & Fabrication
Hantel is widely recognized throughout the medical device industry for our focus and dedication to excellence and quick turnaround. Our highly skilled programmers and journeyman machinists utilize our fully-equipped facility with a CNC machining center and manual mills and lathes. Our personnel provide rapid prototypes and production units with high accuracy and precision.

Plastic Molding imageThermofoming
Hantel's in-house tooling and injection molding operation enables tight integration with manufacturing and assembly operations. In addition, our thermoform tray design and manufacturing capability allows variable production scale, and removes steps in the manufacturing process, because Hantel can package medical devices intended for sterilization.

Supply Chain & Logistics imageSupply Chain & Logistics
Hantel's procurement and inventory management team can assist our clients with purchasing, warehousing and distribution of components and finished goods. This is accomplished through the use of our extensive approved supplier base and MRP system


Quality & Regulatory Compliance imageQuality & Regulatory
Hantel maintains a comprehensive quality system which encompasses design, manufacturing, and service activities. We are licensed by the State of California and registered with the FDA as a manufacturer of Class I, II, and III medical devices. We are also ISO-13485 registered. For products that require FDA clearance prior to entering the market, we can actively manage IDE applications, IRB approvals and 510(k) applications. In addition, through our Annex II certification, we can obtain CE marking for our clients in order to expedite entry into the European market. As your company matures, we can also facilitate the development of your own quality system.

 

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