Scalable Manufacturing Development

Medical device company partners with Meddux to execute design controls, validate critical processes, and establish scalable cleanroom manufacturing for FDA-registered commercialization.

Customer Need

A medical device company developing an innovative ocular irrigation system sought a qualified partner to help advance their product from early development into regulated commercial production. The customer required an ISO-13485 certified and FDA-registered partner capable of completing design and development processes, establishing compliant documentation, and preparing the device for market readiness. Beyond manufacturing capability, they needed an experienced partner able to guide design verification and validation efforts while building the quality and regulatory foundation required for commercialization.

Process

Solution

Meddux executed a comprehensive development and manufacturing solution within the Meddux Quality Management System (QMS), supporting full design history file (DHF) creation, risk management documentation, and design verification execution. Meddux established controlled cleanroom manufacturing, implemented and validated a specialized ultrasonic welding process critical to device assembly, and developed the required protocols, reports, and inspection strategies to support regulatory compliance.

As production matured, Meddux supported continuous improvement by collaborating directly with the welding equipment OEM to specify, install, and validate a replacement ultrasonic welding system without disrupting commercial supply. Meddux provided ongoing regulatory documentation support to enable international market expansion, delivering a scalable, compliant manufacturing framework capable of sustaining long-term commercial production.

Meddux leveraged critical insights from early prototyping to establish a scalable manufacturing solution, ensuring the final design not only met performance requirements but could also transition efficiently from development into full-scale production.

Value Delivered

Meddux was selected as the customer's design, development, and manufacturing partner based on expertise in regulated product development and commercial manufacturing execution. The customer successfully advanced from early development into FDA-registered commercial manufacturing with a fully compliant DHF and validated production processes. Meddux established a scalable cleanroom assembly solution and provided sustained production support, including qualification of equipment to maintain manufacturing continuity, enabling long-term manufacturing stability and readiness for global expansion.

I cannot thank you enough. Your team is exceptional, and I feel so lucky to have been able to find Meddux. I am really excited at how much this device has improved patients' lives. We couldn't have done it without Meddux.

— Founder and CEO, Ophthalmology Startup, USA