Our primary focus is ensuring our customers have the people, processes, and procedures to meet the standards set forth by their governing regulatory bodies. Square-1 Engineering’s qualified cGMP team are immersed in the standards and guidance set forth by the FDA, EMA, and other regulatory bodies which help us execute above expectation on the following projects:

PRODUCT VALIDATION SERVICES:

Device Design Validation and Design Transfer
Test Method Validation (TMV)
Packaging Validation
Software Validation
System Hardware Validation
​

MANUFACTURING VALIDATION SERVICES:

Pilot Process Validation
Facilities IQ/OQ/PQ
Equipment IQ/OQ/PQ
Cleanroom Pre-Certification Validation
Cleaning Validation
GMP Commercial Process Validation
Validation Training
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Validation Master Plans (VMP)
21 CFR Part 11 QMS Gap Assessments
Audit Readiness Preparation
Periodic Validation Reviews
​

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

 SQUARE-1 CAPABILITIES INFORMATION

Square-1 Engineering offers support in a variety of medical device project disciplines across R&D, RAQA and Manufacturing Engineering.  Learn how we engage in each of those phases by clicking on the icon links below covering Square-1 Engineering case studies, medical device industry and project expertise.

CASE
​STUDIES

MEDICAL DEVICE
EXPERTISE

PROJECT
​EXPERTISE

Project Success Profile

1. Discovery
2. Project Planning
3. Deployment
4. Quality Assurance
5. Finish Line
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 success profile process:

Request Information