ISO 13485 Certified · FDA Registered · Class 7 Cleanroom
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ISO 13485 · FDA Registered · Class 7 Cleanroom

Every Component.
Every Tolerance.
Every Record.

Titanium machining, PEEK injection molding, and Class II/III device assembly under one ISO 13485 roof — from first article inspection to validated packaging. Your DHR is complete before you ask for it.

±0.0005"
Held Tolerance
100%
Lot Traceability
<72h
CAPA Response
Audit Our FacilitySee Full Comparison →
Ti-6Al-4VSilicone SealPEEKBaSO₄ MarkerTi-6Al-4V
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Certifications & Regulatory Standing — Auditable On Request

ISO 13485:2016
Quality Management
Medical Devices
FDA 21 CFR 820
Quality System Reg.
Establishment #3014567890
ISO Class 7
Cleanroom
Continuously Monitored
USP Class VI
Biocompatibility
Polymers & Elastomers
ISO 10993
Biocompatibility
Biological Evaluation
ITAR Registered
Export Compliance
DDTC Registration
Criterion 01 — Regulatory Standing

Supplier Qualification Criterion

FDA Establishment Registration & Full Lot Traceability

Your QA team will ask for it on the first call. Device History Records must be complete, current, and retrievable within hours — not days. A single gap in lot traceability can trigger a 483 observation and halt your entire product line.

100%
DHR Completeness Rate, 36-month audit window
Quality engineer reviewing device history records on digital system in cleanroom

Auditable Evidence

Every Record. Every Lot. On Demand.

FDA Establishment Registration
#3014567890 — Active, renewed annually
Lot Traceability Depth
Raw material cert → final assembly → shipping lot, 100% linked
DHR Retrieval SLA
Any DHR delivered within 4 business hours of request
Material Certificates
Ti-6Al-4V mill cert, USP Class VI CoC, RoHS/REACH on file per lot
Electronic Batch Record
Fully paperless eBR system — zero transcription errors

All documentation available for customer audit. Records retained per 21 CFR 820.180 — minimum 2 years post-distribution.

Auditable Evidence

Controlled Environment. Controlled Risk.

Cleanroom Classification
ISO Class 7 (10,000) — particle-counted, continuously monitored
Environmental Monitoring
Continuous particle, temp, humidity, and differential pressure logging
Biocompatibility Testing
In-house cytotoxicity, sensitization, and USP <87>/<88> screening
Gowning Protocol
ISO 14644-compliant, documented personnel qualification
Sterilization Pathways
Dual-validated: EO and gamma — both with full dose audit trails

All documentation available for customer audit. Records retained per 21 CFR 820.180 — minimum 2 years post-distribution.

Criterion 02 — Manufacturing Environment

Supplier Qualification Criterion

ISO Class 7 Cleanroom & In-House Biocompatibility

Most contract manufacturers send biocompatibility samples to a third-party lab — adding 6–10 weeks and a handoff point where traceability can break. Cleanroom classification determines whether your device can even be assembled here. Check both before you qualify.

ISO 7
Class cleanroom — certified & continuously monitored
Technician in full cleanroom gown assembling medical device components under laminar flow hood
Criterion 03 — Vertical Integration & Program Support

Supplier Qualification Criterion

In-House Tooling, PEEK Molding & Dedicated Regulatory Liaison

The moment your program touches three time zones and four vendors, your DHR has a gap. Engineering change orders stall because the molder doesn't talk to the machinist. Your regulatory liaison is shared across forty programs. We built the alternative.

±0.0005"
Held tolerance on Ti-6Al-4V production runs
CNC machining titanium medical device housing with precision cutting tools in industrial facility

Auditable Evidence

One Roof. One Point of Contact. Zero Gaps.

Titanium CNC Machining
Ti-6Al-4V, Grade 23 — 5-axis, ±0.0005" tolerance, in-house
PEEK Injection Molding
Medical-grade PEEK, USP Class VI, validated tooling on-site
In-House Tool Making
Prototype to production tooling — no outsourced mold shop delays
Dedicated Regulatory Liaison
One named contact per program — 510(k), PMA, and post-market
ECO Turnaround
Engineering change orders processed and validated within 5 business days

All documentation available for customer audit. Records retained per 21 CFR 820.180 — minimum 2 years post-distribution.

Supplier Audit Comparison

Your Current Vendor vs. Certify

Twelve line items. The same checklist your QA team will run when they qualify a new contract manufacturer.

Criterion
Typical Contract Manufacturer
Certify
ISO 13485 Certification
Often third-party audited only
Active cert, customer audit access
FDA Establishment Registration
May be missing or lapsed
#3014567890 — current, on file
DHR Retrieval Time
3–5 business days
< 4 business hours, guaranteed
Lot Traceability Depth
Component level only
Raw mill cert → final lot → ship record
CAPA Response Window
30–60 days typical
< 72 hours initial response, documented
Cleanroom Classification
ISO Class 8 or unclassified
ISO Class 7 — particle-counted
Biocompatibility Testing
Outsourced, 6–10 week lead
In-house cytotoxicity & USP <87>/<88>
Sterilization Validation
Single pathway, external vendor
Dual-validated: EO + gamma, in-house audit trail
Engineering Change Orders
4–6 week turnaround
5 business days, validated
Tooling Ownership
Third-party mold shop
In-house — zero dependency risk
Dedicated Regulatory Liaison
Shared across 40+ programs
Named contact, per program
Vendor Count for Full Build
3–5 vendors across time zones
One ISO 13485 facility — end to end
Request Full Capability Matrix →
Begin Qualification

Audit Our Facility. On Your Terms.

Tell us your device class and annual volume. We'll send the Capability Matrix, our current ISO 13485 certificate, and FDA establishment registration — before the first call.

You'll receive within 1 business day:

Current ISO 13485:2016 Certificate
FDA Establishment Registration (active)
Full Capability Matrix (PDF)
Cleanroom Qualification Summary
Sample DHR — your device class
Capacity Note

Q3 2026 Class III assembly slots are 70% allocated. New program onboarding requires 8-week lead time for process validation.

No sales call required. Certification package delivered regardless of next steps.