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. 

Why partner with RQM+ for your clinical trial consulting and management needs? Let’s count the ways: 

  • End-to-End Expertise

    From conceptualization to commercialization, experience seamless support across your device’s full lifecycle.

  • Regulatory Confidence

    Extensive experience navigating FDA, EU MDR/IVDR, and global regulations to mitigate risks and accelerate approvals.

  • Technical Excellence

    Gold standard lab services for chemical characterization, materials testing, and biocompatibility evaluations.

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:

  • Technical documentation

    Comprehensive gap analysis and remediation of technical files to meet MDR standards

  • Clinical evaluation reporting (CER)

    Developing robust CERs aligned with MDR Article 61 and Annex XIV requirements

  • Post-market surveillance

    Strategies for MDR-compliant PMS plans, reports, and periodic safety updates (PSURs)

  • Notified body engagement

    Expertise in preparing and managing submissions to notified bodies

  • Tailored regulatory strategies for navigating U.S., EU, and global markets 
  • Comprehensive remediation support for FDA warning letters, consent decrees, and global audits 
  • Pilot, pivotal, and post-market clinical trials designed to meet regulatory and payer expectations 
  • Expertise in trial design, site activation, and biostatistics  
  • Root cause investigations for medical device and polymer material failures
  • Detailed analysis of mechanical, chemical, and thermal degradation
  • Actionable findings to inform CAPA and improve product performance and reliability 
  • Extractables and leachables (E&L) testing, polymer analysis, and ISO 10993 compliance 
  • Innovative solutions for investigating material failures and contamination issues 
  • Coding, coverage, and payment strategies tailored for medical devices  
  • Health economic analyses to demonstrate value and secure market access

Make Your MedTech Happen

Medical devices save lives, improve quality of care, and push the boundaries of innovation. RQM+ ensures your devices reach their full potential, navigating the complexities so you can focus on advancing healthcare.

Need expert medical device development support? Partner with The MedTech CRO.

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