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Microcap & Penny Stocks : AMERICAN BIOMED, Minimally Invasive Technology (ABMI)
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To: Lhn5 who wrote (561)4/26/1998 9:37:00 AM
From: Jeffrey L. Henken  Read Replies (1) of 2887
 
Larry in answer to your first question I can only say that I have had the opportunity to express the concerns of many of my fellow investors and feel that any criticism and suggestions I have put forth has been taken constructively and used well.

Time will tell.

As for CE Mark question, by June of 1998 in order to sell medical device products in the European Community CE Mark approval will be absolutely required. ISO 9001 certification and CE Mark approval are very similar with only some minor differences. I expect an announcement that CE Mark status has been achieved could come any time now and will certainly beat that June deadline. I did copy and paste an article I found on how important CE Mark is for the future of sales of medical devices in this part of the world. Please read below:

mdiconsultants.com

CE Mark Target Date is Right Around the Corner

If you are presently selling medical devices to the European Community,or intend to sell products there in the near future, your
conformity to the Medical Device Directive is a necessity. After June 1998, if your medical device does not have the CE mark you will be denied entry into the 18 countries that make up the European Community. The CE requirements are quite extensive and unless your medical device is classified as a Type I product, being able to legally claim CE mark clearance(claiming CE mark without meeting the
Directive is a criminal offense) could require ISO9000 Certification as well as a certification of your Technical File.

So, if the European sales are important to your sales and marketing strategies, the time is running out to assure continued uninterrupted access to that part of the world. The European Medical Device Directive must be addressed now.

For more information on what would be required to obtain the CE mark for your medical device, mdi's staff would be available to assist you. Just indicate on our visitor sign in page, the type of medical devices you manufacture or distribute to Europe and we will provide the MDD classification and what would be required to obtain CE mark.

Regards, Jeff

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