Medical Device CNC Machining in Canada

VisionForge machines medical device components on a 2025 Matsuura MX-520 simultaneous 5-axis centre and a Fanuc Robodrill α-T14iAL, in a climate-controlled facility held at 20°C ±1°. In-house tolerance ±0.0001". Materials include Ti-6Al-4V, 17-4 PH in H900, 316 SS, PEEK, and G10. Based in Mississauga, Ontario. AS9100D is in process — the same quality posture translates well to medical device supplier requirements. ISO 9001 partner operations handle turning, precision grinding, and CMM inspection.

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What medical device buyers need from a machine shop

Medical device contract machining sits under ISO 13485 at the device-maker level — VisionForge is a supplier, not a registered medical device manufacturer, and that distinction matters. What we provide to medical customers:

  • Tight, repeatable tolerances — ±0.0001" in-house on both machines, with partner CMM verification to ±0.0002" where the drawing calls for it.
  • Material traceability on every job, certifications traceable to the mill on request. Retained per-job.
  • Thermal control — 20°C ±1° facility, so a 3-hour cycle on a thin-wall Ti-6Al-4V instrument body doesn't drift between morning and afternoon.
  • FAI and PPAP-style documentation on request, including process capability and inspection reports.
  • Single accountable contact through RFQ, first article, and production — the same person owns the file from quote to ship.
  • Material coverage for the implantable-adjacent and instrument-grade materials medical devices actually use: Ti-6Al-4V, Grade 2 CP titanium, 17-4 PH, 316 SS, PEEK, G10, Acetal.

We do not claim ISO 13485. Customers who require machining under their own 13485 quality system can typically include VisionForge as an approved supplier under their supplier-quality agreement. See Quality & Certifications.

What VisionForge brings to medical device work

  • Simultaneous 5-axis machining for instrument bodies, orthopaedic prototypes, surgical tooling, and compound-contour housings. Fewer setups, lower stack-up, tighter tolerance on complex shapes.
  • Palletized 3-axis work on the Robodrill for higher-volume plates, brackets, fixtures, and simpler instrument components.
  • Prototype-to-production continuity on the same spindle, so first-article process data carries directly into production runs.
  • Partner CMM inspection to ±0.0002" via an ISO 9001 partner, with inspection reports delivered with the parts.
  • In-house vibratory finishing as a machining add-on for deburring, edge break, and pre-coating surface prep on medical parts — keeping the part inside our quality system from cut to ship. We do not perform medical-grade passivation, electropolish, or sterilization; those are arranged with qualified partners per the drawing.

Typical medical device parts we machine

  • Surgical instrument bodies and handles
  • Orthopaedic prototypes and developmental hardware in Ti-6Al-4V
  • Instrument trays, housings, and enclosures
  • Imaging and diagnostic equipment components
  • Fluidic manifolds and valve bodies
  • PEEK components for instrument and test fixtures
  • Low-volume production, 10–500 piece runs with FAI
  • Prototype and iteration parts for design verification

For implantable devices, we are not an implant-manufacturing shop. Prototype and developmental implant work is case-by-case, and we will be explicit about what falls inside our current capability.

Materials we machine for medical devices

  • Titanium: Ti-6Al-4V (Grade 5), Grade 2 CP
  • Stainless: 17-4 PH (H900 condition is most common for medical), 316 SS (including 316L where specified), 304, 416
  • Engineered plastics: PEEK, G10, Acetal
  • Aluminum: 6061-T6 (for fixtures, enclosures, non-body-contact parts)
  • Superalloys: Inconel 625, Inconel 718 — rare in medical but available where a program needs them

Material certifications are available on request, traceable to the mill, retained per job. In-house vibratory finishing is available as a machining add-on for deburring, edge break, and pre-coating surface prep.

Quality system and medical documentation

  • Tolerance: ±0.0001" in-house on the MX-520 and the Robodrill. ±0.0002" through an ISO 9001 partner CMM.
  • FAI and PPAP support: first-article inspection packages and PPAP-style documentation on request.
  • In-process probing on the MX-520 with thermal compensation, inside a facility held at 20°C ±1°.
  • Material certifications: traceable to the mill, retained per job.
  • Inspection reports: delivered with parts, in formats agreed at RFQ.
  • Cert status: AS9100D in process. ISO 9001 partner operations for turning, grinding, CMM. We are not ISO 13485 registered — your medical device quality system absorbs us as an approved supplier under your agreement.

How to engage

  • Send a drawing or STEP file. GD&T print plus 3D model preferred. For NDA-gated medical work, we sign before drawings are exchanged.
  • DFM feedback during quoting. We flag feature-level issues in the quote — fixture conflicts, tool access, edge-break radii that fight the part function — before first article.
  • Single point of accountability. One contact through RFQ, first article, production, and re-orders.
  • Supplier onboarding. We complete medical supplier-quality packages, including material certification and inspection-reporting requirements set in your own 13485 system.

Request a capability statement.

Response within 24 hours on most RFQs. Get a Quote

FAQ

Is VisionForge ISO 13485 registered?

No. We are not ISO 13485 registered. Medical device manufacturers typically include VisionForge as an approved supplier under their own 13485 supplier-quality agreement. AS9100D is in process at VisionForge, and the same quality posture translates into medical supplier requirements.

What medical device materials do you machine?

Ti-6Al-4V, Grade 2 CP titanium, 17-4 PH (H900 and other heat treat conditions), 316 and 316L SS, 304 SS, 416 SS, PEEK, G10, Acetal, and 6061-T6 aluminum for fixtures and enclosures. Material certifications available on request, traceable to the mill.

What tolerances can you hold for medical parts?

±0.0001" in-house on the 2025 Matsuura MX-520 and the Fanuc Robodrill α-T14iAL. Final CMM verification to ±0.0002" is available through our ISO 9001 partner.

Do you machine implants?

Prototype and developmental implant work is case-by-case. For implant production, customers should confirm that our supplier status fits their 13485 approved-supplier requirements for implantable devices. We are not an implant-manufacturing specialist.

Do you perform passivation, electropolish, or sterilization?

No. These are arranged with qualified partners per the drawing. We do perform in-house vibratory finishing for deburring, edge break, and pre-coating surface prep, which keeps the part inside our quality system through that step.

Where are you located, and who do you serve?

1578 Finfar Ct, Unit #2, Mississauga, Ontario. We serve Canadian medical device manufacturers and their contract engineering partners across Ontario, the rest of Canada, and US medical OEMs that accept Canadian-sourced machining supply.