Our Expertise & Services

Navigating the complex landscape of IVD and medical device product development requires precision and expertise. We guide our clients through each stage:

• Conceptualization: From ideation to feasibility assessment, we help define product concepts that align with market needs.

• Design and Prototyping: Our team assists in creating robust product designs and developing prototypes for testing. We partner with UX testing labs to conduct usability studies for clients.

• Product Validation: We help clients design validation protocols that are based on CLSI's guidelines. We partner with multiple CLIA labs and clinics to assist clients in conducting clinical evaluation to ensure that IVD and medical products meet clinical performance expectations through rigorous validation studies.

• Manufacturing Scale-Up: Our experts help transition from prototypes to full-scale production, ensuring quality and efficiency. We also assist clients in searching for contract manufacturers in the U.S., Asia, and Mexico.

We provide tailored solutions to clients seeking regulatory clarity. Our ability to interpret and apply regulations ensures successful product submissions and the market launch.

A. Pre-market Requirements

• 510(k) Clearance: We assist in preparing and submitting 510(k) premarket notifications for IVD and medical devices. This pathway is common for moderate-risk devices.

• De Novo Classification: For novel devices without a predicate, we guide clients through the De Novo process to obtain FDA clearance.

• Premarket Approval (PMA): High-risk devices may require PMA, and we provide comprehensive support throughout this rigorous process.

B. Quality Assurance and Manufacturing

• Quality System Regulations (QSRs): We assist manufacturers to establish Quality Management System (QMS) that is in compliance with FDA's QSR and ISO 13485, covering design controls, production processes, and post-market surveillance.

• Good Manufacturing Practices (GMPs): Our team assists in implementing GMPs to maintain product quality and safety.

C. Post-market Requirements

• Establishment Registration and Device Listing: We guide manufacturers in registering their facilities and listing IVD products with the FDA.

• Initial Importing of Medical Devices: We provide service as an US agent to foreign manufacturers. We work with affiliated medical device importing company to help foreign manufacturers import their products to the U.S. market.

• Medical Device Reporting (MDR): We help clients report adverse events and ensure compliance with MDR regulations.