Regulatory Compliance
Quality Management System
CNSystems is certified according to EN ISO 13485, ISO 13485:2016 MDSAP Audit Model Edition 2 and PAL/Japan.
Notified Body
CNSystems' products are manufactured according to the 93/42/EEC directive and is yearly audited through:
mdc medical device certification GmbH
Kriegerstraße 6
D-70191 Stuttgart / Germany
Tel.: +49 (0)711 253597-0
Fax: +43 (0)711 253597-10
Email : This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: www.mdc-ce.de
Certifications/ Approvals
EUROPE
CE-Certification according to directive 93/42/EEC, Annex II
Declarations of Conformity:
USA
FDA-Certification according to 510(k) Clearance
Certification according to UL 60601-1:2003
CANADA
Certification according to CAN/CSA C22.2 No.601.1-M90
Medical Device Licenses:
BRAZIL
Certificate of Compliance according to ANVISA
Patents
CNSystems holds 71 granted and 9 pending patents in 14 different patent families.
