Medical Devices & Healthcare Manufacturing
Precision fabrication, micro-machining, and cleanroom assembly for medical instruments and healthcare equipment.
ISO 13485
FDA Compliant
Years of Experience
Satisfied Customers
Overview
Pearson Manufacturing supports the medical and healthcare industries with a hybrid fulfillment model—offering precision machining, micromachining, EDM, finishing, and ISO Class 7 cleanroom assembly through a combination of in-house capabilities and certified Canadian partners.
Whether you're producing surgical instruments, diagnostic modules, or biocompatible fixtures, our team manages the full process—from quote through final validation—to ensure full compliance with ISO 13485, FDA, and CE standards.
Capabilities We Provide Access To
- Micromachining of titanium, stainless, and PEEK
- Laser micromachining and EDM for fine features
- Cleanroom assembly and subassembly (ISO Class 7)
- Biocompatible surface treatment and passivation
- Electropolishing and surgical-grade finishing
- Custom calibration, test, and packaging fixtures
Why Partner with Pearson?
- Compliance with ISO 13485, FDA QSR, and CE Marking processes
- Biocompatibility, sterilization support, and traceability built-in
- High-precision tooling for R&D, pilot runs, and high-volume production
- Integrated QA, calibration, and cleanroom packaging services
- Regulatory-conscious support teams for medical device programs
Equipment Used In-House or by Our Partners
Depending on certification and scope, we produce medical components at our Ontario facility or via compliant partners with ISO 13485 and FDA systems:
- 5-Axis Micromachining & High-Speed Mills
- Wire & Sinker EDM for intricate geometries
- Laser cutting (fiber, femtosecond, CO₂)
- ISO Class 7 Cleanroom Facilities
- Electropolishing & Biocompatible Coating Tanks
- Calibration, packaging, and sterile prep lines
Typical Applications
- Surgical scissors, clamps, and handles
- Diagnostic cartridge modules & test housings
- Orthopedic implant tools and guides
- Pump housings, valve bodies, and manifolds
- Catheter fixtures and wire form components
- Cleanroom calibration and verification jigs
FAQs
Are your processes ISO 13485 certified?
Yes. Our internal systems and many of our partner facilities are ISO 13485 certified and meet FDA QSR and CE requirements.
Do you support Class I, II, or III medical parts?
Yes—we support components and tooling for Class I, II, and select Class III devices with traceability and material compliance.
Can you provide sterile packaging and validation?
Yes. We offer coordination of sterile packaging and can assist with validation protocols in line with ISO and FDA standards.
Ready for Precision Medical Components?
Share your specifications, CAD files, or validation needs—our team will coordinate compliant fabrication and cleanroom delivery every step of the way.
Request a Medical Devices Quote