Compliance doesn’t stop at market launch. Sustaining your product’s success requires IVD, combination product, and medical device regulatory compliance consulting services that add vigilance, adaptability, and expert guidance throughout your product’s entire lifecycle. We work closely with you to ensure ongoing compliance, proactive risk mitigation, and constant adaptability in the face of evolving regulatory demands.  

Whether it’s post-market surveillance, quality system improvements, or responding to regulatory updates, we give you the support you need to sustain your MedTech innovation. 

When you choose RQM+ for sustaining services, you gain: 

  • Total Product Lifecycle Support

    Maintain compliance and performance throughout your product’s lifecycle.

  • Beyond Compliance

    Gain expert support to meet regulations, and benefit from best-practices that go beyond basic compliance.

  • Regulatory Confidence

    Stay ahead of changing global regulations with expert guidance.

Core Medical Device Regulatory Compliance Services

  • Development and integration of PMS plans and reports 
  • Retrospective post-market clinical follow-up (PMCF) and performance follow-up (PMPF) studies 
  • Periodic safety update reports (PSURs)  
  • Enhancements for ISO 13485, QSR, MDR, and MDSAP compliance 
  • Internal audits and supplier quality assessments 
  • Mock audits and FDA inspection readiness 
  • Strategic responses to audit findings and warning letters 
  • Updates to technical documentation for regulatory changes 
  • Labeling and standards review 
  • Proactive remediation strategies for ongoing compliance 
  • Risk management updates aligned with current global standards 
  • Sustaining support for biological evaluation and material testing
  • Partnered with 19 of the top 20 medical device manufacturers to sustain compliance 
  • Proven success in achieving and maintaining ISO 13485 and QSR certificate
  • Supported clients through complex challenges with a high client return rate

Nobody wants to repeat themselves over and over at different stages of their journey. One partner who can safely guide you from concept to commercialization saves you time, money, and frustration. 

For post-market success, RQM+ brings the expertise, tools, and dedication to ensure your product remains compliant, safe, and impactful — long after launch. We’re your trusted partner for the long haul. 

Make Your MedTech Happen

Stay ahead of post-market challenges with industry-leading medical device regulatory compliance consulting.

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