Medical Devices & Healthcare Manufacturing
Precision fabrication, micromachining, and cleanroom assembly for medical instruments and healthcare equipment.
ISO 13485 (by facility)
FDA/CE (by routing)
Years of Experience
Satisfied Customers
Overview
Pearson Manufacturing supports medical programs with a hybrid fulfillment model — precision machining, micromachining, EDM, finishing, and cleanroom assembly fulfilled either at our Ontario facility or via compliant Canadian partners. We coordinate documentation, inspection, packaging, and logistics so your builds align with ISO 13485/FDA/CE expectations.
Quick Specs
| Workstream | Best For | Speed | Notes |
|---|---|---|---|
| Prototype / R&D | Trials, fixtures, and feasibility builds | Fast | Quick-turn + DFM feedback; flexible materials & finishes |
| Clinical/Pilot | Pre-production with documentation | Medium | Inspection data, traceability, packaging plan |
| Production Units | Repeat components & subassemblies | Medium | Stable routing; lot control; UDI/marking (by routing) |
| Sterile-Ready Packs | Cleanroom packaged builds | Medium | Cleanliness procedures; packaging & records by spec |
Capabilities We Provide Access To
- Micromachining of titanium, stainless, and medical polymers; small-feature pocketing & drilling
- Wire & sinker EDM for intricate internal features and sharp corners (by routing)
- Laser micromachining/cutting (fiber/femtosecond/CO₂) for fine slots & profiles (by routing)
- Electropolishing, passivation, and surgical-grade surface finishing (by routing)
- ISO Class 7 cleanroom subassembly, cleaning, and packaging (by routing)
- Custom calibration, test, and packaging fixtures; ergonomic instrument handles
- Inspection packages: CMM/vision, surface finish results, ballooned reports, traceability
DFM & Standards Tips
- Reserve ultra-tight GD&T for clinical/functional features (bearing lands, sealing faces, cutting edges).
- Break edges (e.g., 0.05–0.2 mm) to mitigate micro-burrs and protect gloves/seals; avoid burr traps.
- Standardize hole/thread families and radii where possible; note any sharp edge requirements explicitly.
- Specify passivation/electropolish targets and any masked surfaces to prevent over-finish on critical fits.
- Declare sterilization compatibility (EtO/steam/plasma) and cleaning chemistry limits to guide process choices.
- Call out UDI/part marking method & placement early to avoid late-stage rework.
We’ll review your model/drawing, cleanliness & documentation requirements, and confirm achievable tolerances and the right routing (in-house or partner) before kickoff.
Why Partner with Pearson?
- Hybrid routing for capability, compliance, and schedule — managed under one QA umbrella
- Regulatory-conscious documentation flow (traceability, inspection, packaging records)
- Micron-scale repeatability using stable fixtures and validated processes
- Prototype-to-production continuity with consistent setups and travelers
- Single point of contact coordinating suppliers, paperwork, and logistics
Equipment Used In-House or By Our Partners
- 5-axis micromachining centers & high-speed mills
- Swiss/precision turning (by routing) and multi-axis lathes
- Wire & sinker EDM; laser micromachining/cutting (by routing)
- Deburr & finishing cells; electropolish & passivation (by routing)
- ISO Class 7 cleanroom assembly/packaging areas (by routing)
- CMMs, optical/vision systems, profilometers; cleanliness/packaging verification
Typical Medical Applications
- Surgical scissors, clamps, handles, and laparoscopic subcomponents
- Orthopedic implant tools, drill guides, and cutting blocks
- Diagnostic cartridge housings, microfluidic manifolds, and ports
- Pump housings, valve bodies, precision manifolds, and fittings
- Catheter fixtures, wire forms, and introducer accessories
- Calibration, test, and sterile-packaging fixtures
Medical & Healthcare FAQs
Are you ISO 13485 certified and FDA/CE compliant?
Select partner facilities hold ISO 13485 certification and operate to FDA QSR/CE requirements; we coordinate compliant routing, documentation, and logistics end-to-end.
Do you support Class I, II, or III components?
Yes — we routinely support Class I & II parts and select Class III components and tooling with lot control, material traceability, and documented inspection.
Can you provide sterile packaging or validation support?
We can coordinate cleanroom packaging and assist with validation protocols (e.g., packaging integrity, load configuration) per your procedures.
What tolerances are realistic?
Baseline: metals ±0.0005–0.002″; plastics ±0.001–0.005″ on critical features. Tighter limits may be achievable after engineering review.
How should I scope my RFQ?
Share CAD + PDF with GD&T, material/finish, sterilization compatibility, documentation list (traceability/inspection/packaging), quantities, and schedule. Start your medical devices quote — include sterilization compatibility, documentation list, and schedule.
Ready for Precision Medical Components?
We’ll coordinate compliant manufacturing, documentation, and cleanroom delivery to your specifications — keeping quality and timelines tight from day one.
Request a Medical Devices Quote