Quality System

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0 height="100%"><tr> <td valign="top" width=200 BGCOLOR="#CC99FF" TEXT="#080000"> <div> <TABLE BORDER="0" CELLPADDING="2" CELLSPACING="0" WIDTH="95" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP HEIGHT= 46 WIDTH="91"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="46" ALIGN="bottom" WIDTH="91" HSPACE="0" VSPACE="0"></tD> </tR> </TABLE></div> <DIV ALIGN="LEFT"></DIV> <div> <B>        </B><FONT SIZE="4" COLOR="#000000" FACE="Arial" ><B>MicroVision</B></FONT></div> <bR> <div> <A HREF="id2.htm" TARGET="_top" TITLE="About Us"><U>About Us</U></A></div> <div> <A HREF="products_page.htm" TARGET="_top" TITLE="Products"><U>Products</U></A></div> <div> <A HREF="id44.htm" TARGET="_top" TITLE="Electronic Catalog"><U>Electronic Catalog</U></A></div> <div> Quality System</div> <div> <A HREF="id37.htm" TARGET="_top" TITLE="How to Order"><U>How to Order</U></A></div> <div> <A HREF="id6.htm" TARGET="_top" TITLE="Contact Us"><U>Contact Us</U></A></div> <div> <A HREF="id40.htm" TARGET="_top" TITLE="Meetings Calendar"><U>Meetings Calendar</U></A></div> <div> <A HREF="id39.htm" TARGET="_top" TITLE="Useful Links"><U>Useful Links</U></A></div> <bR> <div> <A HREF="index.htm" TARGET="_top" TITLE="MicroVision, Inc."><U>Home Page</U></A></div> <bR> <div> <IMG SRC="101241d0.jpg" border=0 width="36" height="29" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <div> <B>0459</B></div> <bR> </td> <td valign="top" BGCOLOR="#FFFFFF" TEXT="#080000"> <bR> <div> <B>Quality System</B></div> <bR> <div> At MicroVision everything comes under the heading of quality. MicroVision has been ISO-9001 and EN46001 certified and uses ISO standards throughout its operations. MicroVision is a registered manufacturer with the FDA and has obtained CE mark for its products in accordance with the Medical Device Directive.</div> <bR> <div> The certificates are available for download at the following links:</div> <bR> <div> <FONT SIZE="3" COLOR="#000000" FACE="Arial" >                      </FONT><B> </B><B> </B><A HREF="id45.htm" TARGET="_top" TITLE="ISO9001 Certificate"><U><B>ISO-9001</B></U></A><B> </B><B>               </B><B> </B><A HREF="id46.htm" TARGET="_top" TITLE="CE Mark Certificate"><U><B>CE</B></U></A></div> <bR> <bR> <DIV ALIGN="LEFT"></DIV> <div> <B>FDA Approvals</B></div> <bR> <div> MicroVision has marketing clearance from the U.S. Food & Drug Administration (FDA) for the following products:</div> <bR> <div> <A HREF="id48.htm" TARGET="_top" TITLE="510(k) Fiber Optic Endoilluminator"><U><B>510(k) Fiber-Optic Endoilluminator</B></U></A></div> <div> <A HREF="id67.htm" TARGET="_top" TITLE="510(k) Scleral Plugs, 19 and 20 Gauge"><U><B>510(k) Scleral Plugs, 19 and 20 Gauge</B></U></A></div> <div> <A HREF="id71.htm" TARGET="_top" TITLE="510(k) Retinal Implants"><U><B>510(k) Retinal Implants (Scleral Buckling Components)</B></U></A></div> <bR> <div> Click on the links above to review a copies of the FDA marketing clearance letters.</div> <bR> <bR> <div> As mentioned earlier, MicroVision is registered with the FDA as a medical device manufacturer.  Please click the link below to review a copy of MicroVision's Annual Establishment Registration:</div> <bR> <div> <A HREF="id49.htm" TARGET="_top" TITLE="Annual Device Establishment Registration"><U><B>Device Establishment Registration</B></U></A></div> <bR> <bR> <div> In addition to the above approvals, MicroVision has received permission from the FDA to export its devices to foreign countries.  To review a copy of MicroVision's certificate to foreign government, please click the link below:</div> <bR> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Certificate to Foreign Government"><U><B>Certificate to Foreign Government</B></U></A></div> <bR> <bR> <bR> <div> These certificates are provided in Adobe Acrobat<FONT SIZE="3" COLOR="#000000" FACE="Symbol" >  </FONT> <IMG SRC="0e520200.png" border=0 width="32" height="32" ALIGN="BOTTOM" HSPACE="0" VSPACE="0">     format.</div> <div>  <A HREF="http://www.adobe.com/products/acrobat/readstep2.html" TARGET="_top" TITLE="http://www.adobe.com/products/acrobat/re"><U><IMG SRC="0e7581f0.png" border=0 width="88" height="31" ALIGN="RIGHT" HSPACE="88" VSPACE="0"></U></A></div> <div> If you need to download the Adobe Acrobat reader, please click the icon to the right.</div> <bR> <bR> <div> If you have specific questions about our quality system, please contact us.</div> <bR> <bR> <div> © Copyright 2003, 2004 MicroVision, Inc.</div> <bR> <bR> <div> Adobe<FONT SIZE="1" COLOR="#000000" FACE="Symbol" >â</FONT> and Acrobat<FONT SIZE="1" COLOR="#000000" FACE="Symbol" >â </FONT>are registered trademarks of Adobe Systems, Inc.</div> <bR> <div> This page last updated 09 Jun 04.</div> <bR> </td> </tr></table></body>