Qualification of testing equipments

Mission :

Proposal for a process of software validation fulfilling the FDA requirement.

Proposal and implementation of a qualification strategy.

Tools validation.

Retro-engineering of a bench of test and redaction of the specifications.

Follow-up of the subcontractor for the checking of the bench of test software.

Writing of the hardware and software qualification plan and course of the tests.

Analyzes of the R&D pledge of the equipment.

Drafting of the preventive maintenance plan of the equipment.

Drafting of documentations for the technicians and the supports teams.

Installation of a new production process

Definition of process, drafting of the documents, training of the teams.

Review and approval of the equipment qualification documents (hardware and software).

Coaching of the “Mammography and Vascular” teams for the qualification of equipment.

Proposal of new templates for the equipment and software qualification.

Technical aspects :

FDA 21CFR Part 820 & Part 11

ISO 13485

ISO 9001 V2000

Functional analysis

Brainstorming

Labview

Charts of acquisition Ni

Coders of position