Plastikon is proud to announce a strategic partnership with Hantel Technologies.
Plastikon/Hantel offers a single-point path for all of your contract projects- from early-stage product development through large-scale high-volume worldwide contract manufacturing, distribution and logistics. Our alliance allows us to become involved in a product’s life cycle as early as initial concept development and see it through final delivery. Our proven expertise in med device and biotech includes human clinical and animal trials and full compliance with all regulatory requirements. We also have incubator experience. From start to finish, Plastikon/Hantel is your partner for all your plastics needs.
- Product Development – Early phase expertise
- Human Clinical & Animal Trials
- Contract Manufacturing
- Injection Molding
- Rapid Prototyping
- Tool Design & Build
- Aseptic Liquid Filling
- Laser Marking and 3D Printing Capabilities
- Regulatory Affairs Expertise
- Part Decoration
- Servicing & Refurbs
- Incubator Partnership – Early stage, revenue generating
Product 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 utilize our proven design-to-manufacturing process to prepare your device for production.
Machining & 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.
Hantel’s highly skilled manufacturing personnel are ready to assist with the assembly and packaging of your medical product. We build in both an ISO Class 8 (100k) certified controlled environment and open floor manufacturing facility, utilizing a variety of manufacturing equipment. Our facilities and equipment are also available for private use by our clients.
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. Our in-house thermoforming further accelerates getting your product to market by eliminating the “middle-man” and providing in-house packaging of medical devices that are intended for sterilization.
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, Hantel can assist our clients in obtaining their CE mark, helping to expedite entry into the European market. As your company matures, we can also facilitate the development of your own quality system.