Validation ServicesOur 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
Support for Medical Device Development
We provide support for medical device needs in R&D, RAQA, and Manufacturing Engineering. Click the icons below to learn more.
The Project Success Path
In the dynamic world of MedTech engineering, our clients present us with a wide range of challenges. That’s why we take the time to listen—understanding the specific needs, constraints, and goals of each project. With this foundation, we tailor our approach to align with project objectives, ensuring precision, efficiency, and successful outcomes. The diagram below illustrates our project success path.
1. Discovery
|
2. Project Planning
|
3. Deployment
|
4. Quality Assurance
|
5. Finish Line
|
White Papers & ArticlesCheck Out the 4-Minute Medical Device Podcast
|
|