Your Guide to Regulatory Approval

Navigating FDA regulations and international standards can be complex, and mistakes lead to costly delays—or worse, non-compliance risks. Regulatory agencies require manufacturers to maintain compliance at every stage, from concept to post-market oversight.
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Square-1’s RAQA services (Regulatory Affairs, Quality Assurance & Quality Control) provide a clear, structured approach to compliance, ensuring quality and regulatory alignment from development through the patient experience.

Regulatory & Quality Services

Bringing a medical device to market requires more than just technical expertise—it demands regulatory precision and a strong quality foundation. Our team helps you navigate approvals, strengthen compliance, and optimize quality systems from development to post-market.

Regulatory Affairs

​Regulatory hurdles can delay product launches and increase costs. We help you develop a clear, strategic approach to compliance and submissions so you can move forward with confidence.
​Our expertise includes:
  • Regulatory strategy & gap analysis
  • FDA/agency meeting preparation & representation
  • IDE, 510(k), PMA submissions
  • Device labeling compliance
  • Complaint handling systems & compliance SOPs

Quality Engineering

​A strong quality system isn’t just about passing audits—it ensures reliability, safety, and efficiency. We design, implement, and optimize quality processes tailored to your needs.
Key services:
  • Design control & quality system implementation
  • Risk management & process validation
  • CAPA/NCMR resolution & root cause analysis
  • Process improvement & cost reduction strategies
  • Supplier management & assessments

Inspection Readiness

Regulatory inspections can be stressful, but with the right preparation, you can turn them into a seamless, predictable process.
We help with:
  • Mock FDA & ISO inspections
  • Risk-based audit preparation (ISO, MDD, MDR, MDSAP)
  • 483/Warning letter response & remediation
  • Hands-on training & experiential learning

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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.

Case Study on Remediation

large_team_remediation_case_study_square-1_engineering.pdf
File Size: 296 kb
File Type: pdf
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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.
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Get the full breakdown in the case study (download left).

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.
1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line

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