OUR QUALITY POLICY

Northern Nitinol develops and manufacturers quality medical device products that meet or exceed customer expectations through a committed and engaged workforce that continually strives for improvement of our quality processes and safety.

FIG. 01 — CORONARY STENT / REV C

BUILT TO TOLERANCE

Every unit that leaves our floor is traced back to the station, operator, and material lot that built it.

Hover the drawing to see how it's specced.

MATERIALNitinol / 316L Stainless
STRUT THICKNESS65 µm
CERTIFICATIONISO 13485 · ISO 25539-2
RADIAL STRENGTH1.2 N/mm

Note: specs, certifications, and figures shown are illustrative purposes only.

3.5 mm ⌀ 18.0 mm

"Through our collaboration with Northern Nitinol and two other partners, the Northern Nitinol team showcased expertise in nitinol, driving the project with a client-centric approach.”

~ Fortune 100 Medical Device Corporation

CERTIFIED QUALITY. INDUSTRY STANDARD.

CERTIFIED QUALITY. INDUSTRY STANDARD

Our quality system follows ISO 13485:2016, supporting controlled and traceable medical-device manufacturing. Every process is held to defined quality and regulatory requirements.

Northern Nitinol processing reaches medical ISO certification for medical device quality management system, standard 13485:2016.

"From concept to production, the Northern Nitinol team prioritized problem-solving and innovation to meet our unique design requirements.”

~ Growing Midwest Medical Device Company