The path to bringing new medical devices to market is filled with regulatory hurdles, technical challenges, and market access nuances. At RQM+, we amass decades of expertise across consulting, clinical trials, lab & material science, and reimbursement strategies to help your product succeed at every stage of its lifecycle.
From innovative product development to post-market surveillance (PMS), we have the tools and experience to make your MedTech happen.
Medical Device Consulting Benefits
Why partner with RQM+ for your clinical trial consulting and management needs? Let’s count the ways:
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End-to-End Expertise
From conceptualization to commercialization, experience seamless support across your device’s full lifecycle.
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Regulatory Confidence
Extensive experience navigating FDA, EU MDR/IVDR, and global regulations to mitigate risks and accelerate approvals.
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Technical Excellence
Gold standard lab services for chemical characterization, materials testing, and biocompatibility evaluations.
MDR Planning and Execution
The European Union’s Medical Device Regulation (MDR) has redefined compliance standards for MedTech companies. This can pose challenges for manufacturers worldwide. RQM+ simplifies this process, offering industry-leading guidance to ensure your products meet MDR requirements efficiently and effectively.
Our MDR Expertise Includes:
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Technical documentation
Comprehensive gap analysis and remediation of technical files to meet MDR standards
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Clinical evaluation reporting (CER)
Developing robust CERs aligned with MDR Article 61 and Annex XIV requirements
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Post-market surveillance
Strategies for MDR-compliant PMS plans, reports, and periodic safety updates (PSURs)
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Notified body engagement
Expertise in preparing and managing submissions to notified bodies