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,
NOT TO LUCK

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

ISO 13485:2016 has been recognized and applied widely as a strict quality control policy for medical devices, hence why we also follow the standard to maintains an industry-wide reputation as a medical device developer and manufacturer with high quality standards. Our skilled technicians enforce the stringent quality, clinical and regulatory requirements.

CERTIFIED QUALITY. INDUSTRY STANDARD

CERTIFIED QUALITY. INDUSTRY STANDARD.

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

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

~ Growing Midwest Medical Device Company