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Medical Device Directive - Class I

Medical Device Directive - Class I

MEDICAL DEVICE DIRECTIVE-CLASS I
EUROPEAN UNION-ENTRY PACKAGE
LEADS TO SELF-CERTIFICATION

Manufacturers of medical devices who export their products to the European countries are responsible for meeting the requirements of the Medical Device Directive MDD by June 14, 1998.

BOTEK offers affordable assistance through its EU ENTRY-PACKAGE.

EUROPEAN UNION-ENTRY PACKAGE CONTENT

RISK CLASS DETERMINATION -

A review of your devices to determine if they are indeed subject to the MDD and if so, which risk classification applies.

Devices are organized into groups in accordance with EN 15225 to minimize the quantity of technical files.

TECHNICAL FILES -

A systematic seven-step system is delivered via e-mail. This system has been designed to produce the required results within a minimum period of time.

The steps are e-mailed in such sequence that repeat is eliminated and documentation is kept to a minimum.

Numerous examples of documentation are provided. Unlimited support via phone, fax or e-mail is included during a two-month implementation period.

SELF-CERTIFICATION

Risk Class I devices only. Upon completion of the technical file you may issue a Declaration of Conformity which you place with your European Authorized Representative. BOTEK will help you.

Once the existing device compliance intelligence has been entered into the CE technical file, the consultant assists with its completion through our existing:

TECHNICAL FILE - EU ENTRY PACKAGE

The seven steps delivered by E-Mail are:

STEP 1 - Organizing the devices into product categories and groups for each technical file and completing a checklist of suppliers and sub-contractors.

STEP 2 - Completing a checklist of existing documentation by product.

STEP 3 - Completing a checklist of existing GMP/FDA - ISO 9000/ISO 13485 documentation, including procedures.

STEP 4 - Identifying, documenting and arranging for the performance of required tests.

STEP 5 - Audit for gaps between existing documentation and the documentation specified in the customized QNET documentation matrix prepared in accordance with the Medical Device Directive.

STEP 6 - Produce missing documents for Risk Analysis and Checklist for Essential Requirements, using examples provided as part of the EU Entry Package.

STEP 7 - Produce missing documents identified in Step 5 using some of the examples provided as part of the EU Entry Package, including the ''''Declaration of Conformity".

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