Product Validation Services:

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

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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

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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.

Case Studies

Medical Device Expertise

Project Expertise

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.

Learn About Project Execution

1. Discovery

2. Project Planning

3. Deployment

4. Quality Assurance

5. Finish Line