The European Market place is the second biggest market for medical technology after the US. Being able to market your medical products in the European Community requires that your product meets the requirements of the Medical Device Directive (MDD) or the In-Vitro Diagnostic Directive (IVDD) that goes into effect in June 2003. Without this CE mark, your device can not be distributed or used by the European Medical Community. We have the expertise to determine your product Type, prepare the Technical File, select an Authorized Person in Europe and contract with a Notified Body.

ISO 9000 is being recognized in the global healthcare community as the standard for quality. We have successfully brought over 45 companies through this certification process. In order to put the CE mark on Type IIa, IIb and III medical device, you would be required to have ISO certification as part of your quality system. We have Internationally Certified Lead Assessors on staff who can assist you to establish your quality system or to convert your present quality system to meet this ISO 9000 standard. After establishing that you have the proper quality systems in place, we can then assist you to achieve ISO 9000 certification. We will train your staff in the ISO standards as well as internal auditing. We will be present during the certification audit assuring that the program is being correctly audited and interpreted.