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Turnkey Projects

Turnkey Projects

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    Medical devices being closely associated with human life are highly regulated and hence it is important that they be designed in the right way. Retrospective compliances usually involve intensive retracing; and twice the effort and time involved. Hence, it is essential that these activities be proactively performed simultaneously with infrastructure development. Maven Profcon Services LLP is a medical device consulting regulatory company that provides regulatory guidance to medical device manufacturers. We help our clients by providing turnkey services such as quality system accomplishment, training, licensing, certification, and regulatory approval.

    Turnkey Projects

    The turnkey projects mostly helpful in areas like:

    • Plant layout preparation and approval
    • Procuring manufacturing approvals
    • Providing options for service providers
    • Consultation for Regulatory aspects during design and development
    • Quality management system
    • Whole technical file construction
    • Clinical evaluation
    • Risk management
    • Training and implementation
    • Post market activities
    • Testing services
    • Compliance & policies
    • Auditing
    • Maintenance services

    We work on all the regulatory and technical hurdles faced by the manufacturer and coordinate & communicate with authorities and regulatory bodies. We closely work with client to reduce the time and work force involvement ensuring minimum financial involvements, hence reducing project costing. With a diverse team, expert in various aspects of medical device development and working methodologically to make the entire process smooth and error-free we cater to the requirements of clients.

    Benefits of turnkey projects:

    • Group of expertise in Maven make sure that the projects comply with all applicable standard and regulatory guidelines.
    • It helps to set out a scope of those project and results are represented very precisely and perfectly.
    • We also help manufacturers create the best manufacturing layout adhering to environmental safety standards, a compliant clean room where required, easy man-material movement, machine installation requirements and ultimately managing the product and process quality requirements and user requirements.

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    June 13th, 2024

    Understanding the Premarket Notification 510(k) Process: Path to FDA Approval

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    June 6th, 2024

    Key Components Of Clean Room Design

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    May 16th, 2024

    Navigating Regulatory Challenges For Drug-Device Combination Products in EU

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