• Healthcare IT / MDDS

    With the recently announced Medical Device Data Regulation (MDDS), more and more Healthcare IT companies are turning to device experts for guidance on how to comply with the new regulation.  These forward-thinking companies see proactive compliance as a way to obtain a key competitive advantage over those companies that are taking a “wait and see” approach and expect to reap the benefits when the FDA starts enforcing the regulation in 2012.

    Sparta Systems is the recognized leader in enterprise quality management systems and helps companies maintain regulatory compliance while also increasing efficiencies.  We appreciate that Healthcare IT is a unique business and are here to help take the things HIT companies do today and make them comply with the FDA’s regulations like 21 CFR Part 820 without adding undue burden to the process.  Sparta excels at helping companies apply the right controls, at the right times, to develop efficient, compliant processes.

    Benefits of TrackWise Healthcare IT / MDDS software: 

    • Complies with regulations, including 21 CFR Part 820 and 21 CFR Part 11 as well as Annex 11, ISO9001 and ISO13485
    • Seamlessly integrates to existing systems; TrackWise is designed to fit alongside your existing infrastructure, not replace everything you do today
    • Demonstrates that Healthcare IT companies are operating in a state of control by linking all quality events together in a closed-loop fashion
    • Enforces document and procedural controls, as well as data security, across the corporation
    • Escalates issues to the appropriate level of management visibility and provides senior management the tools to have true Quality Management reviews and oversight


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