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Regulatory & Compliance

Medtech companies operate in one of the world's most highly regulated environments, where regulatory and quality decisions can directly affect development timelines, commercialization, and ultimately the value of the business. Square-1 provides experienced RAQA expertise to help clients establish the right strategy, build compliant systems, address deficiencies, and navigate regulatory requirements without creating unnecessary bureaucracy. We help clients build quality and regulatory practices which protect the business while enabling it to move forward.
9 Hubble, Irvine, CA 92618
Our Regulatory & Compliance Services
  • Regulatory
    ​Affairs
  • Quality Management
    Systems (QMS)
  • Quality
    Engineering
  • Remediation
    ​Case Study
  • Meet
    ​Frank!

Regulatory Services
​Our expertise includes:
  • Regulatory strategy and planning
  • FDA submission support (510(k), De Novo, and PMA)
  • FDA interaction and response support
  • Labeling

Quality Management Systems (QMS)
Key services:
  • Post M&A integration & planning
  • Development and implementation
  • QMS remediation
  • Quality Management System Regulation (QMSR) readiness and compliance
  • Design controls
  • Risk management / ISO 14971
  • CAPA and nonconformance remediation
  • Complaint handling and post-market support
  • Supplier quality

Quality Engineering
We help with:
  • Process validation
  • Software validation support
  • Internal and supplier audits
  • FDA inspection readiness
  • SOP development and optimization
  • Quality and regulatory gap assessments
  • Fractional or interim RAQA leadership

Remediation Case Study

A Class III medical device company faced multiple FDA 483s following a high-stakes product recall. System-wide nonconformances—spanning QMS, Operations, and R&D Sustaining—put compliance and product integrity at risk. Our team stepped in to navigate the remediation process, helping them regain compliance and rebuild confidence. You can download the case study to the left, or click below to read the blog post.

Medtech compliance got you down?

This is Frank. Frank is overwhelmed with device compliance work. But don't worry, Frank. We're here to help.

Project Success Profile

In the dynamic world of MedTech engineering, our clients present us with a wide range of challenges. That’s why we take the time to listen—understanding the specific needs, constraints, and goals of each project. With this foundation, we tailor our approach to align with project objectives, ensuring precision, efficiency, and successful outcomes. The diagram below illustrates our project success path.

​86% of customers who complete our evaluation process choose Square-1, and 94% say our project performance meets or exceeds their expectations.
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