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ADB Consulting offers our experience in the establishment and execution of product design controls to achieve documentation, compliance and validation to support efforts for the development of a medical devices embedded with software. Our product software validation staff possesses experience and knowledge regarding:

PRODUCT SOFTWARE VALIDATION:

• FDA regulations for the development and manufacturing of diagnostic, implantable, Class I, II, and III medical devices as well as associated industry regulations, such as those by the FDA, AAMI, AIMD, ICH, MDD, ISO, and IEC.
• System development life cycle analysis comprising concepts, design, implementation, installation, integration, maintenance, and requirements.
• Embedded and object-oriented programming languages, as well as Assembly, C, and various others.
• Systems testing with electrical, mechanical or software components.
• Debugging and troubleshooting in hardware, firmware and software applications.
• Version control systems such as CVS, Visual Source Safe, Team Foundation Server, Perforce, Serena ChangeMan, and SubVersion.
• Knowledge of requirement and traceability tools and defect tracking systems.
• Design, interpretation, and documentation of electronic circuits.