IVD Product Registration and Listing Service

Comprehensive regulatory support for diagnostic cartridge and instrument development including FDA, IVDR, and TGA approval guidance. Leverages proven expertise in navigating international regulatory requirements.

Regulatory registration and testing service for active medical devices, passive medical devices, and in vitro diagnostic reagents. Supports compliance with medical device classification, clinical evaluation, and submission requirements for market authorization in regulated territories.

Expert consulting service for in vitro diagnostic product development including assay formulation and integration. Multidisciplinary team provides support in molecular biology, quality control, injection molding, and microfluidics. Accelerates time-to-market for diagnostic solutions.

Full-service in vitro diagnostic development for human, animal, and therapy-related applications from concept to market.

Contract research organization service specializing in in vitro diagnostic test validation. Services include ethics approvals, study design, sample provision, laboratory analysis, and regulatory compliance documentation for EU IVDR, TGA, and WHO standards.

Manufacturing and development service for CE IVD certified diagnostic kits including real-time PCR formulations, controls, and reagent components. Supports custom product development for diagnostics companies.

Specialized service supporting regulatory registration and compliance documentation for endoscope systems and components. Assists manufacturers in meeting medical device regulatory requirements for market approval.

Regulatory support services for medical device market registration, including technical documentation preparation and compliance verification. Facilitates product launch and government approval processes.

A service that facilitates regulatory compliance and market entry for medical devices and in vitro diagnostics (IVDs) in Southeast Asia. This service assists manufacturers in navigating regulatory requirements and establishing their products in the Southeast Asian market.

Professional regulatory services for in vitro diagnostic device clinical registration and certification in European markets. The service ensures compliance with EU requirements and maintains market authorization.

IVDR Certification service for in vitro diagnostic devices, ensuring regulatory compliance with EU In Vitro Diagnostic Regulation requirements. Comprehensive conformity assessment and quality management system certification for IVD manufacturers and distributors.

Regulatory consulting service for medical device and in vitro diagnostic (IVD) compliance across multiple jurisdictions. Provides market access strategy, country representation, and technical guidance to manufacturers navigating IVDR 2017/746 and harmonized standards requirements globally.