Set up and certification of a testing laboratory for medical devices in line with EU Directive 93/42/EEC, transposed into national legislation: Project CEEX-MA-C2-2657





Stage 1.

Researches regarding the conformity evaluation of medical devices for the electrical safety requirements in corellation with the 93/42/EEC directive

  • Analysis of the harmonised standards requirements
  • Design and implementation of necessary installations required to performe the experiments, equipment and standards acquisition.
  • Elaboration of specific procedures

 Deadline: 20.12.2006

Stage 2.

Design of test methods for evaluating medical devices conformity

  • Methods validation. Experiments, Testing
  • Design and development necessary installation for general conditions evaluation, equipment acquisitions
  • Testing, evaluation of devices

Deadline: 30.06.2007

Stage 3.

Documenting the testing laboratory

  • Elaboration of documentation necessary for the preevaluating audit for Internal auditory
  • Documentation changes according to the conclusions from the preevaluating audit
  • Submission of accreditation file to the competent regulatory agency

Deadline: 30.10.2007

Step 4.

Acreditation and dissemination of conclusions

  • Dissemination of conclusions to clients.
  • Laboratory accreditation

Deadline: 20.12.2007