1. MEDevice Forum- San Diego- Sep 13th and 14th. Booth # 408

2. MDM- BIOMEDevice 2011- San Jose – Dec 6th and 7th. Booth # 214

3. MDM West in Anaheim – February 14th to 16th, 2012. Booth # 2170


Come join us at the  Heart Rhythm 2011 event at the Moscone Center in San Francisco – May 5th to 7th. For more information visit the Heart Rhythm website.

Hantel Booth Number: 2041

Dear Friends and Collegues,

Today is the deadline for discounted early registration for the Bay Area Biomedical Device Conference which will be held on March 30, 2011, in the Student Union Building at San Jose State University. More information, including registration information, can be found at the Conference website: roulette flash

Last year’s success has motivated us to plan an even better conference and we have another set of outstanding speakers who will be addressing several aspects that are particularly relevant to the biomedical device industry. We thank our Industry Advisors who have been essential in our selection of the speakers.

We are happy to report that thirteen companies, in addition to the SJSU President’s Office and the national Biomedical Engineering Society, are sponsoring this conference. We take this opportunity to thank our sponsors and co-sponsors. If your company would like to join this elite group of conference sponsors, please do let me know.

Please do register today so that you can take advantage of the reduced early bird registration fee which ends on March 17, 2011. To register please go to:

We would appreciate it very much if you could please forward this announcement to any of your friends or colleagues who you think might be interested as well.

We look forward to seeing you at the Conference on March 30, 2011.

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

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

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