ISO 13485 Certification
Our facility is certified to ISO 13485 and optimized for lean medical device manufacturing. We maintain strict process control, full traceability, and risk-based quality assurance practices that align with FDA and EU MDR expectations. Clients benefit from a mature QMS that scales with their needs — from early-stage production to commercial growth.
Contract Manufacturing (ISO 13485)
Design Transfer
We facilitate a structured and collaborative design transfer process that bridges engineering and production. For startups, we streamline documentation and tooling validation to reduce cost and complexity. Our lean processes eliminate waste and ensure your design is production-ready without unnecessary delays or overhead.
Manufacturing Scale-Up
We help companies move from low-volume to mid-scale manufacturing without sacrificing quality or responsiveness. Our lean-driven scale-up strategy allows for efficient batch size transitions, rapid changeover, and real-time quality monitoring — ideal for companies navigating early market entry or preparing for growth funding milestones.
Pilot Builds
We offer pilot manufacturing runs for clinical trials, verification builds, and pre-commercial evaluation. Our nimble setup is especially suited for startups requiring short lead times and high-touch support. Every pilot lot follows ISO 13485 protocols and lean production principles to ensure consistency, documentation, and rapid iteration.
Supply Chain Management
Our team manages sourcing, procurement, and inventory through vetted suppliers with medical device experience. We implement lean inventory strategies, including just-in-time delivery and demand-based replenishment, to keep costs low and lead times short — particularly important for early-stage companies managing limited capital and volatile demand.
Cable & Harness Assembly
We deliver high-reliability cable and harness assemblies built to medical-grade specifications. Each assembly is produced under controlled conditions with full testing and documentation. Lean layout and workflow optimization allow us to meet custom requirements quickly, making us a dependable partner for both prototypes and production volumes.
RMA & Post-Production Support
We provide end-to-end support for RMA, rework, and complaint resolution. Our quality team handles root cause analysis, traceability, and CAPA in accordance with ISO 13485. This service is especially valuable for startups that need compliant post-market processes without building an internal service infrastructure from day one.