Navigate Your Path to Success

From innovative concept to commercial reality - we bridge the gap where many promising innovations falter.

New Product Introduction (NPI)
Manufacturing Transfer

The Manufacturing Transfer phase is the strategic pivot where your validated design scales from development into efficient, high-volume production. We manage every intricate detail, from process validation to supply chain logistics, ensuring a flawless transition and reliable manufacturing launch for your medical device.

Device Master Record (DMR) Development & Remediation

We develop and remediate Device Master Records (DMRs) to establish complete, compliant, and production-ready documentation that supports efficient manufacturing execution. Each record is structured to provide clear traceability, ensuring alignment between design intent and controlled production processes. In parallel, we integrate Design for Manufacturability (DFM) principles to optimize cost, quality, and scalability. By evaluating materials, component selection, assembly methods, and inspection strategies early in the process, we help streamline production workflows, reduce variability, and ensure your design performs reliably in full-scale manufacturing environments.

Master Process Validation Plan (IQ, OQ, PQ)

We ensure that your manufacturing processes are validated to the highest standards, guaranteeing consistent production of high-quality products. Our robust Master Process Validation Plan encompasses Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), providing a comprehensive approach to process validation.

Supply Chain Establishment & Risk Assessment

We establish a reliable supply chain and conduct thorough risk assessments to ensure a steady flow of materials and components. Our proactive approach guarantees that your production processes run smoothly and efficiently, minimizing potential disruptions and maximizing productivity.

Inventory Control, Storage, and Tracking

We provide top-notch inventory control, storage, and tracking solutions that ensure your medical devices are managed with precision and care. Our state-of-the-art systems guarantee that your products are always in the right place at the right time, ready to meet the demands of the market.

On-Demand Batch Manufacturing & Fulfillment

We offer unparalleled on-demand batch manufacturing and fulfillment services designed to meet your unique needs. Our flexible and scalable solutions ensure that you can produce and deliver your products efficiently, no matter the volume.

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11025 Dover Street
Westminster, Colorado

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