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Hantel Technologies – page 2

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: The use of nitinol in medical devices
Presenter: Louis Malito, NDC

Abstract: Given the alloy’s complex shape memory and super-elastic properties, nitinol is an inter-metallic compound that has found widespread use in the medical device field. Medical devices such as peripheral stents, inferior vena cava (IVC) filters, and guide wires all use nitinol’s superior strain accommodation capabilities in their application. Combined with the right post-processing techniques, nitinol can also exhibit lasting bio-compatibility. Mr. Malito will share a general overview of the unique properties of nitinol and its engineering challenges. Topics to be discussed include material applications, basic nitinol crystallography, engineering aspects, and processing techniques.

Louis Malito is a junior research and development engineer at Nitinol Devices and Components (NDC), an independent, privately held company exclusively focused on Nitinol technology. Louis is a graduate of the University of California, Davis (UCD), where he received his bachelors degree in biomedical engineering with an emphasis in medical device design. Louis served as an adviser to the UCD department of Biomedical Engineering on implementing a medical device-based curriculum. Louis has also served as Vice President of the UCD student chapter of p the Biomedical Engineering Society (BMES). His passion for science and engineering culminated in a student project his senior year (designing and prototyping a nitinol stent as a solution to pericardial effusion) – this experience steered him to explore the world of nitinol engineering.

Date: Thursday, September 29th, 2011
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.
Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: Plasma Surface modification for the life sciences industry
Presenter: Mikki Larner, Plasma Technology Systems

Abstract:
Gas plasma is a powerful method for molecular reengineering of materials to impart unique surface properties, without affecting the bulk properties. The technology is a critical tool for the life sciences industry. Applications include but are not limited to: atomic level cleaning; incorporation of functional species for diagnostic and research tools; deposition of nanometer scale thin film organic coatings to change lubricity, permeation or chemical resistance on devices; and creation of interfacial surfaces for primerless adhesion and overmolding. The effect of plasma on a material is determined by the chemistry of the reactions between the surface and the reactive species present in the process gas employed Liquids may also be introduced as vapors, expanding by many orders of magnitude the potential for unique surface alterations and coatings. The presentation will provide an overview of the diverse plasma processes applied to materials for life science applications. Discussions will include surface stability, surface validation, and a review of common study variables.

Mikki Larner is the Vice President of Sales and Marketing for Plasma Technology Systems (PTS), a Plasmatreat company. Prior to the recent acquisition, she was the PTS President and formerly the Sales Manager at 4th State, Inc. She is a graduate of the University of Florida, Gainesville, receiving a degree in marketing. She has a strong technical understanding of surface modification manufacturing practices, primarily for the life science, aerospace and electronics markets. Activities include memberships in the Surfaces in Biomaterials foundation, Society for the Advancement of Materials and Process Engineering, and the Society of Plastics Engineers Golden Gate chapter where she has held board positions since 2006. She volunteers for the Silicon Valley Engineering Council, and has advised students at San Jose State University, University of Massachusetts Lowell, and South Dakota School of Mines and Technology on plasma applications.

Date: Thursday, January 26th, 2012
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.
Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff

Come join Hantel Technologies at MDM West from February 8th – 10th at the Anaheim Convention Center in booth #2176!

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Hantel Technologies Customer Survey 2012

* (required field)


We would greatly appreciate if you took a moment to rate our customer services.





Did we provide valuable design and engineering services?


Did we provide valuable documentation quality on regulation?


Did our production personnel demonstrate process understanding and product knowledge?


Did we meet our contract commitments using prompt billing methods and sufficient invoice information?

Would you recommend Hantel Technologies to other companies for design and manufacturing of Medical Devices?

U.S. FDA “Approved Materials” for Medical Device Use

The Center for Devices and Radiological Health (CDRH) does not maintain a list of
ingredients or materials that are certified or approved for use in medical devices. That is
because the appropriateness of a material depends on the application. That is why FDA
approves finished devices and not components or materials which could be used in varied
applications. For skin or open wound contact, only short term tests may be needed, where
as for an implant, long term in vivo tests would be recommended.
The responsibility for biocompatibility of a finished device lies with the manufacturer.
This can be accomplished in several ways, one of which is to assess or characterize all
components of a device according to the ISO 10993 standard. Some testing can be
avoided if biocompatibility data is available from the component supplier. Many
component suppliers are aware of the biocompatibility requirements that finished device
manufacturers must meet and will supply testing data to meet those needs. Use of
previously qualified components with a known safety profile can save the finished device
manufacturer time and money.

It is the responsibility of each device manufacturer or specifications developer to assure
that all ingredients and component materials are suitable for their intended purposes.
The finished medical device must be safe and effective for its intended purposes when
used according to its labeling. In this context, safety and effectiveness include many
parameters such as physical properties, chernical properties, and biological effects,
including the biocompatibility of materials that contact human tissue.

If you have reviewed ISO 10993 and the ASTM methods (F748) you should be able to
develop a rational plan for documenting the biocompatibility of your device. If you are
unsure of the minimum testing requirements contact DSMICA at:

DSMlCA@fda.hhs.gov and advise them of your device and indication for use. They will identify the correct division within the Office of Device Evaluation (ODE) for you to start a dialogue.

Published by FDA for MDamp;M Anaheim 2-8-2011 to 2-10-2011

Here at Hantel we are always trying to serve our clients with the highest standards of services from all of our departments, and we would greatly appreciate any feedback on how we can improve these services. Please take a few minutes to fill out our Customer Satisfaction Survey and let us know how we are doing.

Welcome to our newly updated website! Feel free to browse our new sections including the Webinars page or Register an account, and don’t forget to check back in for the latest from Hantel Technologies.