RQM+ Takes a Risk-Balanced Approach to Design History Files

We provide regulatory risk mitigation that aligns with your business goals and process improvement that adds business value.

  • Design History File Support from Pre-Market Through Post-Market Device Development

    When you involve RQM+ from the beginning, our design quality engineers have the ability to develop processes to effectively utilize and document design controls to create a compliant design history file. Because we act as a strategic partner that always has your business goals in mind, we develop design controls and documentation practices that can improve and prevent future issues across all product lines.

  • Acquisition Support

    DHF deficiencies are commonly found in due diligence and a significant item to address post acquisition. Our project managers and cross-functional SMEs can support you with creation of a risk-based remediation plan and execute across all DHF elements, with minimal burden on your team.

  • MDR and IVDR Implementation

    It is not uncommon for manufacturers with legacy products to find that their design history files do not meet EU MDR or IVDR requirements. Considering the tight timeframe, we recommend a proactive approach to ensuring your design history file documentation is MDR/IVDR ready, reducing notified body review time and minimizing questions.

    Learn more about our approach.

  • US FDA Audit Preparation

    RQM+ can help you respond to an FDA warning letter or 483 that identifies deficiencies in your design history files, but the best practice is to always be ready for an inspection. Whether you have a scheduled inspection coming up or have concerns about your documentation, we are here to help.

  • Combination Products

    For products that contain both pharmaceutical and device elements, design history files are a critical component of compliance. RQM+ medical device experts can support you with optimizing your DHF's and creating sustainable processes for efficient ongoing file maintenance.

    Design History Files That Go Beyond Compliance 

    The RQM+ team includes seasoned product development experts who have decades of experience with medical devices and IVDs—we understand your devices. We also understand the business value of maintaining design history files to enable a smooth process for design changes and quick responses to audits, field issues, or complaints.   

    Learn more about our regulatory compliance services.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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