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.
Benefits of a quick Gap Assessment:
Our one-day gap analysis offers fast, focused insight so your team can stay ahead of potential issues:

Locate critical gaps quickly

Allows your team to act before small issues escalate

Flag potential non-conformances

Reduce risk of rework by flagging potential non-conformances early

Save time & money

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

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

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