As regulations become more abundant and rigorous, medical device companies face increased challenges maintaining compliance and operational effectiveness.  Conducting gap assessments can help your organization maintain quality standards while improving efficiencies all while reducing potential hazards in the future. 

​At Square-1, we offer a collection of single-day, cursory gap assessment services designed to provide quick and actionable insights into your operation, helping you stay within regulatory guidelines while delivering the best medical device products to your end users.
BENEFITS OF A QUICK GAP ASSESSMENT
Our cursory gap assessments get to the heart of the matter FAST by focusing on critical areas and uncovering potential non-conformances; it’s also a cost effective approach allowing our customers to identify ahead of time issues and areas for enhancement while helping our customers avoid rework.

KEY FOCUS AREAS FOR ONE-DAY GAPS

+ M&A DUE DILIGENCE READINESS

+ QUALITY MGMT SYSTEM (QMS)

+ MANUF. CAPACITY OPTIMIZATION

+ SUPPLIER & OUTSOURCING CONTROLS

+ QUALITY CONTROL PROCESSES

+ LABOR & RESOURCE ALLOCATION

+ RISK MANAGEMENT PROCESS

+ POST MARKET SURVEILLANCE

LET'S TALK GAPS: REQUEST A CALL WITH SQUARE-1

Solidworks Quick Tips: 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 length video click HERE