Scale cleanroom assembly without building your own infrastructure
Class 5–8 cleanrooms, precision kitting, and multi-site capacity under one quality system
Scaling assembly volume without internal cleanroom infrastructure is expensive and slow. You either invest millions in equipment and facilities, or juggle multiple vendors and risk quality escapes at every handoff. Either way, you're managing redundant quality systems and compressed timelines — while your device launch date keeps slipping.
What You Get
Class 5–8 Cleanroom Assembly
High-precision cleanroom assembly environments matched to your device classification — from implantables to diagnostics consumables. One ISO 13485 certified quality system replaces vendor patchwork, meaning fewer audits and simpler compliance.
Precision Kitting
Complete device system kitting that reduces vendor touchpoints and ensures every component arrives together, validated, and documented.
Bioabsorbable Processing
Specialized solvent scouring and polymer processing for bioabsorbable and implantable devices — including Class 7 dry room access. A capability most CMOs lack.
Multi-Site Capacity & Redundancy
Three facilities across California, New Hampshire, and Costa Rica. If demand spikes or a site goes down, your supply doesn't stop. Qualified processes transfer across locations so you scale without revalidating.
Audit-Ready Documentation
Complete device history records, batch traceability, and assembly documentation structured for FDA inspection or customer audit. Your QA team reviews our DHRs, not chases them.
How It Works
Discovery Call
30-minute call with a manufacturing engineer to understand your device, volume, complexity, and timeline.
Facility & DFM Assessment
Review CAD and BOM, identify the right cleanroom class, and flag any assembly considerations. 1–2 weeks.
Quote & Agreement
Pricing based on volume, cleanroom class, and setup labor. No surprises — transparent line-item quoting.
Setup & Validation
Kitting jig design, procedure validation, and first-piece QC. Typically 2–4 weeks.
Production & Ongoing Support
Scheduled production runs, real-time status updates, and regular quality review meetings.
When You Need This
Get a quote for your assembly and kitting needs
Tell us about your device, volume, and timeline. Our manufacturing engineering team will assess your cleanroom and kitting requirements within 48 hours. Best fit for Class II/III medical devices requiring controlled-environment assembly.
What Happens Next
Who
A manufacturing sales engineer with cleanroom assembly expertise
When
Within one business day of your submission
About
Device details, volume forecast, timeline, and facility preference (CA, NH, or Costa Rica)
Frequently Asked Questions
It depends on your device classification and the nature of the assembly. Class II sterile devices typically require Class 7 or Class 8 environments, while implantables and devices with direct tissue contact often need Class 5 or Class 6. During our discovery call, we'll review your device specs and recommend the appropriate cleanroom class — we operate Class 5 through Class 8 across all three facilities.
From first contact to validated production typically takes 6–10 weeks, depending on device complexity and cleanroom class. Setup and validation (jig design, procedure validation, first-piece QC) is usually 2–4 weeks after quoting. If you need surge capacity, our multi-site footprint across California, New Hampshire, and Costa Rica means we can shift volume between facilities without requalifying.
Yes — this is one of our specialized capabilities. We operate a Class 7 dry room and have validated solvent scouring processes for bioabsorbable and implantable polymers. Most contract manufacturers don't have the controlled-humidity environment or the material handling expertise that bioabsorbables require. If your device uses PLA, PGA, PLGA, or similar polymers, we can process it.
Every production run includes complete device history records (DHRs), batch traceability records, in-process inspection data, and final release documentation. Everything is structured for FDA inspection or customer audit — your QA team can review our records without chasing them down. We also maintain full lot traceability from incoming components through finished goods.
It's not required, but we recommend a visit during the DFM assessment and first-article inspection. Many customers send their manufacturing or quality engineer for 1–2 days during setup. After validation, production runs are managed remotely with real-time status updates and scheduled quality review meetings.
All three facilities operate under one ISO 13485 certified quality management system. Procedures, training, and quality standards are identical across California, New Hampshire, and Costa Rica. This means one audit covers all locations, and processes transfer between sites without revalidation. Your quality team deals with one QMS, not three.
We follow a formal CAPA process for any nonconformance. Root cause analysis begins within 24 hours, with containment actions implemented immediately. You receive a full investigation report with corrective and preventive actions, and we track effectiveness over subsequent production runs. Our goal is to prevent recurrence, not just fix the symptom.