Medical Device Consulting: R&D Engineering | Manufacturing Engineering | RAQA
Home  >  Services  >  Consulting  >  One Day Gap Assessment

One-Day Gap Assessment

Get Started

Quick Insight. Long-Term Impact.

At Square-1, we understand that it's challenging for medical device companies to balance compliance and operational effectiveness. And it's only getting more difficult, as regulations grow more rigorous and change over time. That's why we offer a Gap Assessment, to help our clients maintain quality standards, improve efficiencies, and reduce potential hazards.

Our single-day, cursory Gap Assessment is designed and tailored to client needs. We provide quick and actionable insights into your operation, helping you stay within regulatory guidelines while delivering the best medical device products to end users.
Get Started
Benefits of a quick Gap Assessment:
Our one-day gap analysis offers fast, focused insight so your team can stay ahead of potential issues:
Picture

Locate critical gaps quickly

Allows your team to act before small issues escalate
Picture

Flag potential non-conformances

Reduce risk of rework by flagging potential non-conformances early
Picture

Save time & money

Saves time and money with a focused, cost-effective approach to process improvement
Get Started

Key Focus Areas for One-Day Gap Analysis

Our gap analysis it structured to quickly home in on the areas that impact compliance, scalability, and product quality. Our team tailors each review to your needs. These are just some of the topics that we've helped our clients navigate:
  • M&A Due Diligence: Ensure your systems and processes are acquisition-ready
  • Quality Management System (QMS): Identify gaps in documentation, procedures, and implementation
  • Manufacturing & Resource Planning: Spot inefficiencies in labor, capacity, or process scalability
  • Supplier & Outsourcing Controls: Evaluate vendor oversight and compliance safeguards
  • Risk Management & Post-Market Surveillance: Strengthen proactive risk identification and tracking
Get Started

Resource Feature: Solidworks Tips for Enclosure Surfacing

In this video our team demonstrates how to use the sweep and loft functions to create complex shapes; once the console is complete we recommend splitting the model into multiple parts to aid in proper design for manufacturing (DFM) and ease of assembly.

For the full video click here

White Papers &​ Articles

Picture
Check Out the 4-Minute Medical Device Podcast
Picture

Site ​Navigation

Home
Services
Case Studies
Medtech Snapshot Podcast
White Papers/ Articles
​Contact Us
Picture

Contact Us

1-844-300-SQR1
Web Content Copyright  ©   2016-2025
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers >
      • Careers - Marketing Generalist
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us
  • Services
    • Consulting >
      • Product Development
      • Regulatory and Quality Compliance
      • Validation
      • Manufacturing Engineering
      • One-Day Gap Assessment
    • CAD for Medical Devices
    • Technical Training >
      • Medical Device Training
  • Project Execution
    • Case Studies
    • Problems We Solve
    • How We Engage
    • Project Expertise
  • About Us
    • Vision & Mission
    • Our Team
    • Careers >
      • Careers - Marketing Generalist
  • Resource Library
    • Medtech Snapshot Podcast
    • White Papers and Articles
    • Southern California's Medical Device History
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • Contact Us