Certificates
Diagnosys LLC is an ISO 13485:2016 / MDSAP certified corporation with FDA-registered medical device establishment. Diagnosys’ systems are CE marked and FDA 510(k) cleared and also has products installed worldwide with country specific medical device approvals where required. All Diagnosys systems are RoHS compliant as well as ETL marked.
MDSAP Certificate
Diagnosys LLC has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of:
ISO 13485:2016
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6)
Canada: Medical Devices Regulations – Part 1- SOR 98/282
United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)
Japan: MHLW Ministerial Ordinance 169, Article 4 to Article 68; PMD Act
EC Certificate
Diagnosys LLC’s full quality assurance system has been certified by Intertek SEMKO AB (0143), a Notified Body according to Directive 93/42/EEC on medical devices. Conforming to Directive 93/42/EEC on Medical Devices, Annex II excluding (4) entitles Diagnosys LLC to use the CE Mark on our electrophysiology equipment.
Patents
US 10,820,824
US 11,357,442
US 11,497,911
US 10,893,823
JP 6,796,642
Trademarks
ColorDome: 88059275
Celeris: 88059184
Espion: 88059226
DiagnosysFST: 88912071