At RQM+, our medical device testing services provide the expertise, technology, and regulatory support to overcome even your most daunting challenges. From extractables and leachables (E&L) analysis to post-market surveillance, we offer comprehensive solutions to accelerate your product’s path to market.  

With over 40 years of experience, our gold standard testing methods (via Jordi Labs, an RQM+ company) are trusted globally, ensuring your devices meet and exceed the highest regulatory requirements. 

When you partner with RQM+ for MedTech device testing, you gain: 

  • Comprehensive Testing

    Specialized capabilities in E&L, material characterization, and polymer analysis.

  • Regulatory Confidence

    Proven methods tailored to meet FDA, ISO, and global regulatory standards.

  • Streamlined Development

    Efficient testing processes that reduce your time to market and mitigate your risks.

  • State-of-the-Art Facilities and Equipment

    Advanced labs equipped with cutting-edge technology to ensure reliable testing and fast results. 

Core Medical Device Testing Services

Our analytical lab services for medical devices include:

  • Comprehensive assessments for regulatory requirements 
  • Proprietary coverage-based methods for accurate identification and quantification 
  • Deep know-how to support FDA and global regulatory submissions 
  • Advanced analysis of polymers, additives, and contaminants 
  • Failure investigations and quality control solutions 
  • PFAS testing services 
  • Comprehensive testing and risk assessments for global market approval 
  • Tailored support to speed your trek through complex regulatory pathways 
  • Guidance on toxicological risk assessments and material selection 

Delivering Real Results 

Our focused, client-centric approach and deep pool of experienced team members — including former regulators — put you in a prime position to succeed: 

  • Supported regulatory submissions for top global medical device manufacturers 
  • Proprietary methods frequently cited in scientific and regulatory guidance 
  • Equipped with cutting-edge technologies, including advanced spectrometry and chromatography 

Medical Device Testing Services Made Easy 

Your medical device deserves the best support to ensure safety, compliance, and market success. With RQM+, you gain industry-leading expertise and a globally trusted partner to guide you toward success every step of the way. 

Make Your MedTech Happen

Partner with RQM+ for the gold standard in medical device testing services.

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