Overview
If you ever wonder, how to turn an exciting idea and/or a cutting-edge technology into a marketable IVD product, or anything in between, you are in the right place. Helical Sphere offers guidance and services to U.S. and international in vitro diagnostic device (IVD) developers and manufacturers for IVD product development and realization.
Consultation Services
Helical Sphere services encompass product realization, quality assurance and control, regulatory affair, and management support.
Technical Feasibility
Product Development
Design Control
Raw Material Quality Control
Establishment Implementation
Quality Improvements
Quality Audits
FDA Clearance & Approval
Lab Developed Tests
IVDR-based CE Mark
Project Management
People Management
Site Management
Helical Sphere is not confined to the past. We are passionate about the cutting-edge technology improvement and ever-changing regulatory landscape that are shaping our world today.
With a commitment to innovation and sustainability, Helical Sphere offers a comprehensive suite of professional services that cater to a diverse clientele, ranging from IVD developers to large-scale manufacturers, with diverse projects from biomedical research, to product development.
Helical Sphere is the bridge that transforms dreams into remarkable realities in bringing cutting-edge technology to consumers.
