Precision machining for medical device components.
Prototype and production components requiring clean documentation, tight tolerances, controlled material lot management, and the ability to scale from first article to repeat production.
Requirements
What this industry typically requires.
- Material lot traceability
- Documented inspection on critical features
- Surface finish control on patient-contact and mating surfaces
- Repeatable production process
- Clean handling on finished components
Capabilities
Relevant capabilities.
Swiss Turning
Production-ready capability with documented inspection and DFM review.
5-Axis Machining
Production-ready capability with documented inspection and DFM review.
CNC Milling
Production-ready capability with documented inspection and DFM review.
CNC Turning
Production-ready capability with documented inspection and DFM review.
CMM Inspection
Production-ready capability with documented inspection and DFM review.
Applications
Typical part types we machine for this industry.
- Surgical instrument components
- Implantable device fixturing and tooling (non-implant components)
- Diagnostic equipment housings
- Fluidic and dispensing components
Engineering & compliance
What to know about working with us in this space.
A short list of the technical and compliance considerations that shape how we quote, produce, and document parts for the medical device sector.
Northline is ISO 9001:2015 certified. Northline does not currently hold ISO 13485 or FDA registration.
We support medical OEM programs where ISO 9001 controls and lot traceability are sufficient.
FAQ
Medical Device — FAQs
The questions engineering and procurement teams ask most often before a first quote.
Are you ISO 13485 certified?
No. Northline is ISO 9001:2015 certified and supports medical programs where ISO 9001 quality controls and material lot traceability meet the requirements.
Can you control material lots for traceability?
Yes. Material lot control and certified material documentation are available on request.
Can you provide surface finish control on critical features?
Yes. Surface finish requirements are reviewed at quoting and verified per the drawing requirements.
Quote Medical Device
Have a medical device part for review?
Upload your CAD files or drawings and our engineering team will review the project requirements.