Quality
Quality Management
Our ISO 9001/ISO 13485 registered and QSR compliant quality system meets all the requirements for Europe, United States, and Canada. Routine audits conducted by our clients keep our system robust. Our clients can adopt the Hantel Quality System or enlist us to aid in the design of a new quality system which better suits their specific needs.
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Document Control
While our team satisfies the tight schedules of Medical Device start-ups, we maintain the discipline of a large company document control structure. The Hantel document control system is available online 24/7, providing secure electronic file management, document change orders, supplier lists, training and equipment records, documentation templates, and more. Component Inspection: Hantel Quality conducts first-article inspections and lot inspections. We operate two shifts 5 days a week for efficient component inspection.
Documentation Templates
Hantel clients have access to a plethora of engineering test procedures, standard operating procedures, and documentation templates. Hantel Templates are compliant with ASTM, AAMI, IEC, and other recognized standards.
Regulatory
We offer expertise in regulatory strategy as well as assistance with evidence and data preparation for submissions.
Technologies
- NIST-traceable dimensional, load, pressure, and flow measurement inspection
- Arena PLM Solutions, Zebra Designer, Adobe Acrobat, AutoCAD, and SolidWorks software
- Documentation searching through the Nerac search engine
- 2-D and 3-D drafting
- Advanced equipment including vision measuring system , 20-inch optical comparator , digital storage oscilloscope , digital measuring instruments and force gauges, and high-pot.
Quality Policy
“We, at Hantel Technologies, are committed to delivering quality products and services that meet and exceed our customer requirements. We routinely measure our performance against defined quality objectives. It is our policy to take appropriate and timely corrective action when needed to ensure that we continue to provide the required services and products. We commit to meeting the Medical Device Directive and other statutory regulatory requirements.” (QM 1001, Rev. K)
