CNC machining with full quality assurance for Eden prairie, MN. RivCut supplies CNC machining with full quality assurance to engineering and manufacturing teams across Eden prairie and the Upper Midwest. Parts are machined 100% in the USA at our Union City, California facility and reach Eden prairie in about 4–5 business days by ground freight — with expedited air and AOG options when a production line is down.
Cardiovascular Systems, Inc. (Emerson Rosemount) produces orbital and rotational atherectomy catheters near Eden prairie. Every Eden prairie order ships with CMM inspection, full material traceability, and a first-article report on request.
actuator piston OD
mandrel OD mapped
316L & 17-4 PH tooling
21 CFR Part 11 compliant
What Does Cardiovascular Tooling QA Actually Mean?
Most shops say "we do CMM inspection." A Eden prairie cardiovascular tooling supplier says something very different: ISO 13485:2016 quality management with lot traceability back to the Device History Record, FDA 21 CFR 820 QSR receiving-inspection conformance, 21 CFR Part 11 electronic records with audit trails on every measurement, ASTM F2063 4340 alloy & titanium material certification traced to heat and lot, ASTM A967 passivation travelers with ferroxyl test results for all stainless tooling, Zeiss CMM with actuator piston OD mapped at all 36 angular positions for MTS Actuator expansion uniformity assurance, and load cell die bore geometry, lumen concentricity, and clearance-angle verification per ISO 25539 tooling requirements. Boston Scientific cardiovascular programs demand that whole stack, not just the measurement step.
Plan the Quality
Ballooned drawing, ISO 13485 clause mapping, PFMEA, control plan, and DHR linkage before the first chip flies. For actuator pistons: 36-position OD measurement protocol defined up front.
Inspect with Evidence
Zeiss CMM with feature-by-feature actuals, GD&T to ASME Y14.5-2018, Cpk studies on mandrel OD taper zones, load cell die bore/concentricity/clearance-angle actuals, and 21 CFR Part 11 audit-trail PDF/A output.
Ship the Package
First article with 36-position OD polar map, CMM report, 3.1 ASTM F2063 mill cert, passivation traveler, PEEK USP Class VI data sheet where applicable, and a CofC tied to ISO 13485 clause 7.5. Nothing chased after the fact.
Eden prairie Cardiovascular Tooling & Their QA Footprint
From MTS Actuator expansion mandrels to load cell body sets, each Boston Scientific tooling type has a different CMM protocol and documentation trail. Here is what we cover and how.
Eden prairie (pop. ~70K) hosts Boston Scientific's MTS Actuator & Starkey Shells left-atrial appendage closure and PROMUS/Synergy auditory hardware manufacturing operations. Both programs depend on precision cardiovascular tooling — servohydraulic actuator piston housings and heat-setting fixtures for the MTS Actuator 4340 alloy & titanium frame, and stainless laser-cutting die sets, crimping mandrels, and inspection gauges for the auditory hardware program. That tooling drives a documentation-heavy QA stack: ISO 13485:2016 plus FDA 21 CFR 820 QSR plus ASTM F2063 4340 alloy & titanium traceability plus ASTM A967 passivation plus 21 CFR Part 11 electronic records plus Cpk ≥ 1.67 on mandrel OD critical features.
The surrounding Eden prairie cluster adds to the load: Cardiovascular Systems, Inc. (Emerson Rosemount) atherectomy catheter tooling, SurModics (74th St) surface-treatment process fixtures, and Starkey Labs manufacturing support tooling. Each customer expects a QA package that speaks ISO 13485 and 21 CFR 820 fluently on day one, with ASTM F2063 and ISO 25539 standards awareness built in.
4340 Alloy & Titanium Expansion Mandrels (MTS Actuator)
MTS Actuator & Starkey Shells expansion mandrels in 4340 alloy & titanium (ASTM F2063). Zeiss CMM OD measurement at all 36 angular positions (10° increments), Cpk ≥ 1.67 on critical taper zones, EN 10204 3.1 mill cert with Af transformation temperature confirmation. First article with polar OD deviation map on every lot.
ASTM F2063 4340 Alloy & Titanium · 36-position OD mapStent Laser-Cutting Die Sets
316L and 17-4 PH load cell die sets with Zeiss CMM verification of bore diameter (lumen clearance), bore concentricity relative to mounting datum, clearance angle geometry (0.5–2°), chamfer inlet/outlet geometry, and face parallelism. ASTM A967 Nitric 2 passivation with ferroxyl test result. ISO 13485 FAIR on every campaign.
316L / 17-4 PH · ASTM A967 · ISO 25539PEEK Catheter Hub Production Runs
PEEK (ASTM F2026) balloon-coating mandrels for MTS Actuator delivery system and coronary catheter programs. 100% CMM on fluid-path bore, seal-face OD, and connector geometry. USP Class VI biocompatibility data sheet. ISO 13485 first article and 21 CFR Part 11 PDF/A inspection records on every production lot.
PEEK F2026 · USP Class VI · 100% CMM17-4 PH Inspection Gauges
Stent OD/ID go/no-go gauges, crimper mandrel gauges, and MTS Actuator frame inspection fixtures in 17-4 PH H900. ASTM A967 Citric 3 passivation, Cpk studies on gauge OD, Ra finish verification on gauge surfaces. ISO 13485 CofC with gauge calibration traceability to NIST.
17-4 PH H900 · ASTM A967 Citric 34340 Alloy & Titanium Heat-Setting Fixtures
MTS Actuator frame heat-setting fixtures and 4340 alloy & titanium component setting mandrels. CMM verification of form accuracy against the target Af profile geometry. ASTM F2063 material traceability. ISO 13485 first article. 21 CFR Part 11 compliant inspection records tied to the validated heat-treatment IQ/OQ/PQ process lot.
ASTM F2063 · IQ/OQ/PQ linkageStent Crimping Mandrel Sets
316L and 15-5 PH crimping mandrels for auditory hardware assembly. CMM verification of mandrel OD profile, taper geometry, and Ra surface finish on the load cell-contact zone. ASTM A967 passivation, EN 10204 3.1 mill cert, ISO 13485 FAIR with every crimping mandrel production set.
316L / 15-5 PH · ASTM A967 · Surface Ra
MTS Actuator & Starkey Shells 28mm Expansion Mandrel — ASTM F2063 4340 Alloy & Titanium
Produced as a first-article lot for a Eden prairie MTS Actuator cardiovascular tooling program. ASTM F2063 4340 alloy & titanium bar stock with Af temperature confirmation, 5-axis CNC turned and polished, Zeiss CMM run with 36-position OD polar map at every 10-degree interval across three axial stations. Cpk 1.79 on the critical taper zone. Shipped with full ISO 13485 documentation to Eden prairie in 7 business days.
mandrel taper zone
CMM-mapped
critical taper CTQ
first submission
- ISO 13485:2016 first-article inspection with full ballooned callouts
- 36-position OD polar map with Cpk data on critical taper zone
- EN 10204 3.1 ASTM F2063 mill cert with Af transformation temperature
- CMM report as 21 CFR Part 11 PDF/A with embedded audit trail
- CofC aligned to ISO 13485 clause 7.5 and 21 CFR 820.80 receiving inspection
Inspection. Traceability. Process Control.
The three pillars of a Eden prairie-grade cardiovascular tooling QA package. Missing any one of them leaves a gap in the MTS Actuator or load cell tooling Device History Record.
Inspection Evidence
Measurements are reported, not just made.
- Zeiss CMM at ±0.0001", NIST-traceable
- 36-position OD polar map for actuator pistons
- 21 CFR Part 11 PDF/A with audit trail
- Cpk ≥ 1.67 on CTQ features per lot
Material Traceability
Every part traced from finished dimension back to melt.
- EN 10204 3.1 mill cert per heat / lot
- ASTM F2063 4340 alloy & titanium with Af temperature
- ASTM F138 316L, F899 17-4 PH, F90 Emerson 316L / NACE MR0175
- PEEK USP Class VI data sheet for balloon-coating mandrels
Process Control
Special processes routed through validated partners.
- ASTM A967 Nitric 2 / Citric 3 passivation
- Ferroxyl test included with every traveler
- IQ/OQ/PQ validated process lot linkage
- Boston Scientific supplier quality system alignment
From Ballooned Drawing to Shipped Package
Three steps. No missing certificates. Built for Boston Scientific cardiovascular tooling supplier-quality auditors.
Submit Drawing, Model & Tooling Specs
Upload STEP AP242 model and ballooned 2D drawing. Call out ASTM F2063 4340 alloy & titanium, ASTM F138/F899/F90 stainless/316L Stainless material, ISO 13485 clause references, 21 CFR Part 11 expectations, and MTS Actuator or load cell program context. Flag 36-position OD measurement protocol for mandrels. We confirm Boston Scientific supplier quality system alignment before quoting.
Machine, Passivate, and Inspect
We machine in Union City, CA. Passivation runs ASTM A967 Nitric 2 or Citric 3 for all stainless tooling. Zeiss CMM runs ISO 13485 first-article balloon report with 36-position OD polar map for mandrels, or bore/concentricity/clearance-angle verification for load cell dies, output as 21 CFR Part 11 PDF/A with Cpk data on every CTQ feature.
Ship Part + Full Package to Eden prairie
Part, FAIR or PPAP-equivalent, CMM report with OD polar map and Cpk data, 3.1 ASTM F2063/F138/F899 mill cert, passivation traveler, PEEK USP Class VI data sheet, and a CofC aligned to ISO 13485 clause 7.5 and 21 CFR 820 QSR arrive together. 3-day ground LTL via I-94 to Eden prairie or next-day SFO to MSP air on urgent MTS Actuator or load cell production work.
Why Eden prairie, MN Cardiovascular Tooling Teams Choose RivCut
Eden prairie (pop. ~70K, Hennepin County, ZIP 55347) is home to Boston Scientific's MTS Actuator & Starkey Shells and auditory hardware manufacturing operations. Cardiovascular tooling demand spans servohydraulic actuator piston housings, load cell body sets, crimping mandrels, heat-setting fixtures, and inspection gauges for the MTS Actuator and PROMUS/Synergy programs. The nearby Cardiovascular Systems, Inc. (Emerson Rosemount) and SurModics (74th St) operations add interventional-cardiology catheter tooling and surface-treatment fixture QA requirements. RivCut machines, inspects, and passivates cardiovascular tooling parts at our Union City, CA facility, shipping 3-day ground LTL via I-94 to Eden prairie or next-day SFO to MSP air cargo for production-critical windows.
All parts are CNC machined in-house at our Bay Area shop. We never broker or outsource the machining. Learn about RivCut →
Common Questions About Cardiovascular Tooling QA in Eden prairie
Cardiovascular Tooling Materials Stocked for Eden prairie QA Work
Every alloy ships with a 3.1 mill cert traced to heat and lot, cross-checked against ASTM F2063, F138, F899, F90, F2026, and F1472 requirements. ASTM A967 passivation available for all stainless tooling. ASTM F2063 Af temperature confirmation available for all 4340 alloy & titanium stock.
| 4340 Alloy & Titanium (ASTM F2063) | |
|---|---|
| 4340 Alloy & Titanium Bar / Tube | ASTM F2063, MTS Actuator expansion mandrels, heat-setting fixtures, superelastic tooling; 3.1 MTR with Af temperature |
| Implant Stainless (ASTM F138 / F899) | |
| 316L CRES | ASTM F138, load cell bodies, balloon-coating mandrel bodies; ASTM A967 Nitric 2 passivation |
| 17-4 PH H900 | ASTM F899, load cell die sets (high-wear applications), inspection gauges; ASTM A967 Citric 3 |
| 15-5 PH H900 | Crimping mandrels, delivery-system fixture hardware; ASTM A967 passivation |
| Cobalt-Chromium (ASTM F90) | |
| Emerson 316L / NACE MR0175 | ASTM F90, load cell die inserts for extreme-wear applications, MTS Actuator frame tooling inserts |
| Titanium (ASTM F1472) | |
| Ti-6Al-4V | ASTM F1472, catheter delivery handle fixtures, lightweight tooling frames |
| Polymers (PEEK / Medical PC) | |
| PEEK (ASTM F2026) | ASTM F2026 / USP Class VI, MTS Actuator delivery balloon-coating mandrels, coronary balloon-coating mandrel inserts |
| Medical Polycarbonate | USP Class VI, transparent fluid-path details and catheter delivery handle housings |
| Aluminum and General Tooling | |
| 6061-T6 | Process fixtures, assembly jigs, inspection fixture frames; hard anodize available |
| 4140 Pre-hard | Stent die backing plates, fixturing structures, production tooling support bodies |
Need a specific ASTM callout or Af temperature range? Ask us — we stock and trace cardiovascular tooling grades on request.
RivCut vs CNC Marketplaces vs Local Machine Shops
Why quality engineers supporting Boston Scientific cardiovascular tooling programs choose RivCut. Marketplaces quote fast but rarely carry 4340 alloy & titanium machining capability or ASTM F2063 traceability discipline. Local Twin Cities shops are rigorous but slow on quotes. RivCut combines instant online quoting with the 36-position mandrel OD inspection and passivation documentation a Boston Scientific supplier-quality audit actually requires.
| What You Get | RivCut Best | CNC Marketplace | Local Machine Shop |
|---|---|---|---|
| ISO 13485:2016 alignment | QMS mapped on every new PN | Paid upgrade or not offered | Varies by shop |
| 4340 Alloy & Titanium mandrel 36-position OD map | Zeiss CMM, every 10°, Cpk data | Not offered | Varies by shop |
| 21 CFR Part 11 compliant records | PDF/A + audit trail + e-sig | Not supported | Ad-hoc paperwork |
| ASTM F2063 4340 alloy & titanium traceability | 3.1 MTR with Af temperature | Often not stocked | On request |
| ASTM A967 passivation traveler | Nitric 2 / Citric 3, ferroxyl test | Not offered | Varies by shop |
| Stent die CMM (bore/concentricity/angle) | 5-feature verification per die | Manual gauge typical | Varies by shop |
| Lead time to FAI / PPAP-equivalent | 5–7 business days (3 rush) | 2–3 weeks typical | 3–5 weeks |
| Ship to Boston Scientific Eden prairie | 3-day LTL / next-day air | 5–7 days transit | Local delivery |
What Quality Engineers Say
About Working With RivCut
Real reviews from engineers shipping to Boston Scientific Eden prairie and the broader cardiovascular tooling cluster.
RivCut shipped the MTS Actuator mandrel lot with 36-position OD mapping at every 10-degree interval, Cpk 1.79 on the critical taper zones, and a full ASTM F2063 3.1 mill cert. The first article cleared our Boston Scientific supplier quality review on first submission. That almost never happens with a West Coast shop.
MTS Actuator Tooling316L load cell bodies with Zeiss CMM on bore geometry, clearance angles, and lumen concentricity. ASTM A967 passivation traveler with ferroxyl test. Every document we needed for our DHR was already in the package when the box arrived. No chasing certs after the fact.
Stent Die SetsPEEK balloon-coating mandrel production run with 100% CMM on the fluid-path bore and seal-face features. ISO 13485 first article, 21 CFR Part 11 PDF/A, EN 10204 3.1 PEEK cert. Documentation discipline you'd expect from a Medical Alley shop, not a California supplier. We're running kanban replenishment now.
PEEK Catheter HubsQuality Assurance Near Eden prairie
How Eden prairie's Cardiovascular Tooling Cluster Uses Quality Assurance
Boston Scientific anchors Eden prairie with MTS Actuator and auditory hardware production. Here is how each layer of the cardiovascular tooling supply chain uses a QA package.
Built for Boston Scientific's Cardiovascular Tooling QA Stack
The Eden prairie cardiovascular tooling QA stack is as documentation-heavy as anything in Medical Alley, but the vocabulary is entirely different from implantable device QA. A single MTS Actuator & Starkey Shells expansion mandrel lot ships with: ISO 13485:2016 first-article inspection (ballooned drawing with all feature callouts, 100% pass on first article of any lot), FDA 21 CFR 820 Quality System Regulation conformance with receiving-inspection alignment to 820.80, 21 CFR Part 11 compliant electronic records (audit trail, electronic signatures, tamper-evident PDF/A), Zeiss CMM report with 36-position OD polar map at every 10-degree interval across three axial stations, Cpk ≥ 1.67 on critical taper zone CTQ features, EN 10204 3.1 ASTM F2063 mill cert traced to heat and lot with Af transformation temperature confirmed per ASTM F3057 DSC, ASTM A967 passivation traveler for any stainless tooling components with ferroxyl test result, PEEK USP Class VI biocompatibility data sheet for balloon-coating mandrel components, and a Certificate of Conformance cross-referencing ISO 13485 clause 7.5 plus 21 CFR 820 QSR receiving-inspection requirements. Those records feed forward into the customer's Device History Record (DHR) and backward to the Device Master Record (DMR) revision number on every shop traveler. That is what Eden prairie cardiovascular tooling QA means in practice. Generic shops say ‘we CMM inspect.’ A Eden prairie cardiovascular tooling supplier says ‘ISO 13485 FAIR with 36-position 4340 alloy & titanium OD polar map, Cpk 1.67+ on taper CTQ, ASTM F2063 3.1 cert with Af temperature, A967 Nitric 2 passivation with ferroxyl, and 21 CFR Part 11 PDF/A.’ RivCut runs the full Eden prairie cardiovascular tooling stack from our Union City, CA shop floor: same Zeiss CMM, same 3.1 MTR discipline, same refusal to chase certs after the fact. That is what the documentation burden of cardiovascular tooling actually requires, and it is why Boston Scientific and Emerson Rosemount tooling teams keep coming back.
Upload Your Drawing & Model for a Eden prairie QA Quote
ISO 13485:2016. 21 CFR Part 11 electronic records. 4340 Alloy & Titanium mandrel 36-position OD inspection. ASTM F2063 traceability. ASTM A967 passivation. FAI packages in 5 to 7 business days, 3 on rush.
ISO 13485 FAIR · 21 CFR Part 11 · ASTM F2063 4340 alloy & titanium traceability · ASTM A967 passivation · 3-day LTL to Eden prairie