Regulatory, Quality &
Engineering Services
Built on over a decade of hands-on medical device development — from biosensor design and process validation to FDA submissions and quality systems. We bring that depth to your team.
Core Competencies
Regulatory & Submissions
We prepare and support FDA submissions — 510(k)s, Special 510(k)s, and pre-submissions — managing the documentation and strategy so your device reaches market with confidence.
- 510(k) & Special 510(k) Preparation
- Design History File Development
- Design Verification & Validation
Design Engineering
From 3D CAD modeling and reverse engineering to production-ready drawings, we deliver the technical documentation your manufacturing partners need.
- 3D CAD Modeling & Reverse Engineering
- Production-Ready 2D Drawings
- STEP, STL & DWG Deliverables
Quality Systems
From gap analysis and CAPA investigations to design controls and process validation — we build and refine the documentation that keeps your QMS audit-ready under ISO 13485 and 21 CFR Part 820.
- Gap Analysis & Design Controls
- Usability Engineering (IEC 62366-1)
- CAPA Documentation & Root Cause Analysis
Supply Chain & Manufacturing Support
We evaluate manufacturing processes, source qualified suppliers, and coordinate packaging and sterilization validation — giving you clear cost comparisons and a vetted path to production.
Industries
We Serve
From Class II/III cardiovascular devices to consumer health platforms and single-use surgical instruments.
Cardiovascular & Critical Care
15 years developing biosensors, blood gas analyzers, and continuous monitoring systems for cardiovascular applications — including design verification, CAPA resolution, and manufacturing process validation.
Consumer Health Devices
Regulatory submissions and DHF management for connected health platforms, including Class II blood pressure monitoring kiosks deployed across thousands of retail locations.
Surgical Instruments
End-to-end support for single-use surgical devices — manufacturing process evaluation, supplier sourcing, and coordination of packaging and sterilization validation per ISO 11607 and ISO 11137.
Let's Talk About
Your Next Project.
Whether you need regulatory submission support, quality system documentation, or engineering design services, we're ready to integrate with your team and get it done.