Our Extended Team of Specialized Independent Contractors & Consultants

SMEs I Proven Abilities I Diverse I Niche Engineering Talent I Problem Solvers I Vetted Specialists

Bridging the Gap: Where Engineering Meets Total Compliance

MEDTECH - QCS strives to provide a variety of experts to help your product development effort be successful. Whether a Startup or mature company, we realize that often you may need more than just one resource and one stop shopping can be really efficient and effective.

Therefore - in addition to our core quality and compliance support, we integrate vetted, experienced experts to apply design controls, best practices, and assure compliance while working to provide the design, development, and manufacturing support you may need. The company Founder meets and interviews every Contractor or Consultant to assure they meet the necessary requirements to fulfill the role.

Our Contractors and Consultants are experts in their field - examples below:

MedTech SMEs - hardware & software development Engineering, Electrical Engineering, QA and Regulatory Experts, and Mfg. Engineering

Examples of how we provide Solutions:

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*We currently have the subsequent resources available:

(Send an email or schedule a time to discuss your needs.)

  • Experience: 10+ Years in Medical Device Regulatory Affairs

    🔹 Education: Graduate in Regulatory Affairs for Drugs, Biologics, and Devices (Northeastern University)

    🔹 Certifications: Regulatory Affairs Certification (RAC) – US, Canada, EU, and Central Asia | ISO 9001 Lead Auditor

  • Fractional Leadership support, 510(k) review, assistance, and completion, Complaints and CAPA process Audit and overhaul, QMS Audit and Certifications, Nonconformance resolution, etc.

  • Quality planning, Hazard Analysis, Risk Management, FMEAs, V&V, Sample Size Determination, Data Analysis, Residual Risk Review…

  • Sr Mechanical Engineer within our network who brings 15+ years of medical device and Life Sciences R&D experience straight to your project.

  • Research, Pre-Sub Mtgs, 510(k) writing, Cybersecurity Analysis and Controls, issue and delay resolution, etc.

  • Complex System Architecture: Lead mechanical design for patient-worn monitors, wearable drug-delivery devices, fluid delivery systems, and disposable surgical catheters.

    Design for Manufacturing (DFM): Experienced-level approach to design for manufacturing, tooling, assembly fixtures, and high-volume injection molded components.

    Advanced CAD Modeling: Heavy utilization of SolidWorks and On shape for multi-component medical devices and precision tooling

  • 11 Years of Medical Device R&D (across point-of-care diagnostics, wearables, and robotics).
    Master’s in Electrical and Computer Engineering.

    Electrical design and troubleshooting.

*These resources are located all over the country; therefore, they work primarily remote with on-site visits as required and agreed upon.

Note: if you have an interest in becoming an Independent Contractor or Consultant in a related position, then send us an email to start the conversation.

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