CASE STUDY

Regulatory Submission of a Connected SaMD

• Supporting a Startup to Achieve
510(k) Clearance via eSTAR

• From No QMS to 510(k) submission

Immagine

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Assess Your Compliance Readiness

  • check markIdentify current compliance gaps 

ShapeStrenghten your SaMD Submission 

  • check markClose critical compliance gaps through risk management, documentation
  •           and validation
  • check markIntegrate cybersecurity and validation measures 

Build your FDA Strategy

  • check markPerform the FDA submission process avoiding costly compliance issues

The Journey Starts Here

  • check markTrust experts to to provide consulting and technical support to help clients align with applicable medical device and regulatory requirements. 
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There Are No Regulatory Shortcuts To SaMD

Software is increasingly playing a key role in how we deliver real-time diagnostics and offer remote monitoring to patients in the digital age. Since the Covid-19 pandemic, the use of software not just as part of a standard medical device but also as a standalone tool for diagnosis, treatment, and disease management has grown rapidly. Since its formalization as a standard industry term in the 2010s by the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device (SaMD) has evolved into a promising sector within the broader medical technology sector.

How PQE Group Helped a Digital Health Startup Enhance Its Path to FDA Alignment

While our client, a digital health startup, had a promising connected SaMD product built to collect patient data from wearables, which it would analyze in the cloud and give personal recommendations to patients, the absence of properly structured QMS documentation posed serious threats to its regulatory success. After a thorough gap assessment by our experts, we found a number of critical gaps, including incomplete risk management processes and fragmented or missing validation evidence, which would have jeopardized the SaMD’s alignment with FDA requirements. Realizing this, our cross-functional team of PQE experts stepped up to the challenge and transformed the identified gaps into a robust, FDA-ready submission.