Supply Chain & Logistics

Protecting the Product from Dock to Door.

Post-Market Logistics

The product journey doesn’t end at assembly. We manage the complex logistics of sterilization and distribution, ensuring your sterile barrier systems hold up in the real world. By integrating logistics into the manufacturing phase, we reduce lead times and eliminate the risks associated with multi-vendor handoffs.

What We Offer?

Sterilization Management (EO, Gamma, E-Beam)
Coordination with validated sterilization partners to ensure your device is safe for clinical use.
Packaging Validation (ISO 11607)
Rigorous testing to ensure your sterile barrier remains intact throughout the rigors of shipping and handling.
Global Distribution & Traceability
Implementing UDI (Unique Device Identification) systems for full transparency across the global supply chain.
Inventory & Warehousing
Climate-controlled storage solutions that ensure your components and finished goods are protected and organized.
Vetting and monitoring sub-tier suppliers to ensure your entire bill of materials meets medical-grade standards.
Coordination with validated sterilization partners to ensure your device is safe for clinical use.

Have a project in mind?

Early Concept Design & Development
Regulatory Strategy
QMS Implementation
Project Development & Precision Manufacturing
Supply Chain & Logistics

Get a free consultation?

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Meet with our team

What began over coffee-fueled brainstorming sessions has grown into a thriving consulting practice dedicated to helping get your project to market with minimal stress.

Eric Klumper

founder | head engineer

Kelsey Lee

Founder | Head of Regulatory Affairs
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Our approach is straightforward— We engineer bold, defensible regulatory strategies that push your device through the FDA and into the field.

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