Product Development & Industrialization Transfer
Correct classification, compliance with key quality and regulatory standards, successful audits, complete documentation, validated clinical evidence
Regulatory complexity
Faster development, defined clinical needs, sample access, cost-efficient studies, clear regulatory strategy
Early-stage uncertainty
Efficient, scalable processes with optimized material use enabling robust assay setup, controlled pilot production, minimized process variability, full GMP compliance, and on-time commercialization
Development & Scale-up
Smooth operations, in-house expertise, trained teams, and regulatory compliance, ensuring efficient transfers, proper training, and controlled process risk
Organizational & operational
Regulatory-ready products, smooth market entry, minimal rework
RUO-to-IVD transition
Turning Your Challenges into Results
From Development Challenges to Industrial Success
Accelerated, de-risked path from concept to market
Cost-efficient, compliant, reproducible processes
Smooth transition from research to industrialized IVD products
Your benefits with Helio
End-to-End Support for IVD & RUO Products
Choose Helio for ...
Comprehensive Product Development and Industrialization Support
Development & Transfer, Robust Process & Validation
ISO 13485-certified QMS, audit-ready teams, regulatory pathway guidance (Compliance with 21 CFR Part 820, IVDR, ISO 13485)
Documentation templates, design control, DHF, performance evaluation reports
Preparation for regulatory submissionsand audits (CE marking, 510(k))
Regulatory &
Compliance Support
Concept & Feasibility, Development, Verification & Validation, Scale-Up
Rapid prototyping, assay optimization, risk management (FMEA, usability, traceability)
Pilot production & scale-up: manufacturing procedures, QC, packaging, labeling, user handbook, GMP-compliant processes, process transfer, manufacturing readiness
Development &
Technical Expertise
RUO Product Development, Training, Labeling, Process Risk Analysis
Faster innovation cycles, tailored assays, minimized outsourcing, IP protection
Early implementation of design controls for smooth RUO → IVD transition
Dedicated industrial support, comprehensive transfer documentation, compliant label creation