The Starting Point for Startups

Navigating the FDA

Quroba provides a technology platform powered by industry experts in regulatory, quality, and compliance to provide business forward solutions helping early stage medtech companies get to market faster.

Check out our Digital Health/ MedTech Winners

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Senior Quroba Team

  • Evan Tsang

    Evan Tsang

    20 years leading product development and ensuring quality in small and large companies.

  • Kwame Ulmer

    Kwame Ulmer

    20 years leading organizations and guiding private companies through the FDA (>1,000 device reviews).

  • Kelly Chu

    Kelly Chu

    20 years developing medtech and digital solutions for healthcare and life science companies.

  • Soumya Mahapatra

    Soumya Mahapatra

    20 years leading transformative technology approaches to business operations.

What we can do for you

Quroba is a technology platform powered by industry experts in regulatory, quality, and compliance to provide business forward solutions helping medtech companies get to market faster.

Quroba

RA/QA as a Service

Quroba's “RA/QA as a Service” has a phased and tiered pricing structure based on the company's current progress to commercialization.

2 - 10 employees

Tier 1 (R&D)

  • Deploy initial design controls
  • Quality Roadmap
  • eQMS Setup
  • Conduct regulatory assessment or develop executive regulatory strategy
  • 10 hours consultation a month

5 - 15 employees

Tier 2 (FDA submission)

  • Deploy complete Design controls
  • Policies review and optimization
  • eQMS execution
  • eSubmission
  • Comprehensive Regulatory Strategy
  • Regulatory application writing and oversight
  • 20 hours consultation a month

15 - 100+ employees

Tier 3 (Post Market QMS upgrade)

  • Review design controls and GMP
  • Internal audit
  • Management Review/Controls
  • Quality and compliance recommendation
  • eQMS Migration
  • Regulatory remediation
  • 40 - 80 hours consultation a month

Additional Capabilities

  • SDLC execution
  • Post market support
  • Remediation
  • QMS Automation
  • Regulatory intelligence

Regulatory Services

  • Regulatory Strategy created by former FDA regulators helps accelerate business success
  • Business strategic leaders
  • Technical writers

Developed serial submission strategy to pull in revenue in partnership with CEO that addressed all regulatory requirements

“As a medical device startup CEO with a complex regulatory strategy and a carefully managed budget… He proactively communicates, patiently supports timelines and milestones through every challenge, and sees the projects through to their best outcomes. Kwame is a connector for his clients as well, going beyond his own projects to ensure his teams are best positioned holistically for fundraising, regulatory and clinical success, and ultimately exit.”

Tracy Macneal

Tracy MacNeal
CEO Materna Medica

Quality & Compliance Services

  • QMS deployment
  • Quality training
  • Quality Engineering
QA Matrix
Amber Norbeck

“We are developing the first robotic dose assembly system for opioid treatment programs, which can be managed remotely. The Quroba platform has helped us get our eQMS up and running and their team is supporting us in getting our policies and procedures in place.”

Amber Norbeck, CEO
Opio Connect

eQMS Platform

  • Document Management
  • Design History File Management
  • Automated Traceability Matrix
  • Workflow Automation
  • Risk, Deviation, CAPA Management
  • Electronic Signature
  • Supplier Management
eQMS Platform
Eric Rodriguez

“Quroba was paramount in streamlining our quality documentation process automation. Our newly integrated QMS software has allowed TLS to have clear traceability with the ability to pull any relevant documentation when needed.”

Eric Rodriguez, Lead Product Manager
Transparency Life Sciences

FDA
Submission
Platform

Streamlines and enforces discipline for first-time submission success

FDA Submission

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demo