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At Design Quality Services (DQS) LLC, we have helped customers manage poor product designs and substandard design documentation for years. We know what good looks like as we have defended our practices and client documentation with agencies and regulatory bodies worldwide. It seems there is never enough time to complete a device development project; however, poor design practices often lead to late design rework or a failed product submission. Utilizing robust engineering methods and a quality-minded culture will go a long way toward minimizing these challenges. Let us help you on your journey.
DQS Specializes in...
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Design and Development processes
​With decades of experience, let us make these activities easier:
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User Need articulation
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Design Input definition
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Design Verification / Validation strategies
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Addressing:
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DHF gaps
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QMS Non-conformances
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Audit Findings
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EU MDR/IVDR transitions
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Risk Management planning
​Risk reduction is central to a safe medical device. Your Risk Management File (RMF) frames almost every element of your business. We focus on:​
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Hazard / Hazardous Situation / Harm identification
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Risk Control Measure (RCM) verification
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Risk estimation / evaluation
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Engineering tools and applications
We help companies accelerate the innovation pipeline through the use of engineering tools
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Failure Mode and Effects Analysis (FMEA)
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Usability Engineering (UE)
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Design of Experiments (DoE)
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Sample size selection
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Control charts for manufacturing
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Contact
At DQS we mean what we say about supporting innovators. Let's talk about how we can help you unclog your technical and quality teams.
+1 269 720 7373