When a compliance issue threatens your progress, regulatory findings from agencies like the FDA, notified bodies, and other global authorities can disrupt operations and delay your product’s success. Additionally, significant regulatory changes like the EU MDR and IVDR, can require extensive updates to technical documentation and quality systems. Mergers and acquisitions (M&A) can also require remediation support integrating quality systems, aligning regulatory documentation, or addressing compliance gaps that are exposed during due diligence.
What’s your best move at this critical time? Partnering with a team filled with former regulators and industry insiders.
At RQM+, we specialize in creating a culture of quality to accelerate your compliance and speed market success, all while minimizing risks. With decades of medical device regulatory support experience, we guide you through every step of the remediation process. When quality matters most, RQM+ has your back.
Your Medical Device Remediation Services Benefits
Partnering with RQM+ for remediation ensures:
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Swift Regulatory Resolutions
RQM+ has supported thousands of FDA and EU submissions — Expedite your responses to findings from global regulatory agencies.
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Improved Compliance Confidence
We develop long-term compliance strategies that strengthen quality systems and align with evolving regulations, including EU MDR, IVDR, and FDA QMSR — Define and implement sustainable solutions that meet international standards.
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Operational Continuity
Whether you’re responding to regulatory findings, integrating quality systems post-M&A, or addressing new compliance requirements, we ensure your operations stay on track — Minimize disruptions and maintain your business’s momentum.
Core Remediation Services
Helping Our Partners Put Remediation in the Rear View
- Partnered with leading medical device manufacturers to address FDA warning letters and global audit findings
- Supported clients in achieving successful remediation outcomes through comprehensive quality system redesigns and strategic regulatory engagement
- Helped clients navigate consent decrees with tailored compliance strategies and ongoing oversight
Device-Specific Expertise
Looking for tailored solutions for your specific product type? Explore our dedicated pages for:
Comprehensive IVD, Combination, and Medical Device Regulatory Support for Remediation Needs
Regulatory challenges don’t have to derail your success. With RQM+ by your side, you can address compliance issues confidently. Let’s tackle your compliance obstacles together and safeguard your MedTech product’s long-term impact.