We know one thing to be true, a good quality system focuses on sustainability. Furthermore, we know the difference between ‘good enough’ versus 'world class' and when each should be employed. Square 1 ’s Quality Engineering & Compliance Services offer a practical yet methodical approach to developing and implementing the proper control processes to maintain quality from development through the patient experience.

QUALITY ENGINEERING SERVICES:

Design Control Process/Design and Implementation
Quality Systems Design & Implementation
Statistical Experimental Design
Risk Analysis
Process and Test Method Development
Software Development/ Systems Integration
Process/ Product Quality Issue Resolution (CAPA/ NCMR)
MDD to MDR Transition
Verification & Validation
Cost Reduction Strategies
Process Optimization/ Improvement
Technology Transfer
Process Automation
Production Equipment Relocation
Training & Education
Program & Project Management
Supplier Acquisition & Assessments
Document Control

INSPECTION READINESS SERVICES:

Simulated Inspections
ISO, MDD, MDR, MDSAP Audit
Risk-based Preparation
Inspection Oversight and Management
Experiential Learning for SMEs
483/Warning Letter Responses
Training & Education

PRODUCT EXPERIENCE:

Class I, II (a & b), III
Delivery Devices
Diagnostics
Disposables
Endovascular
Neurovascular (stents, coils, catheters)
Ophthalmics (IOLs & ICLs)
Plastic Injection Molded Components
Sensing & Monitoring Systems
Surgical Instrumentation
Vision Systems
Wellness Devices

How We Ensure Successful Project Execution

Our clients enjoy working with us because of our proven ability to deliver results beyond their expectation using a systematic, yet flexible approach to project engagement, delivery and successful closure.

Learn more about our project engagement process:

Request Information