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Regulatory/QA
This page contains information
regarding AtCor Medical Quality Assurance status and
Product Regulatory Approvals.
Quality
Assurance
AtCor Medical's
manufacturing plant, which is based in Sydney Australia, is
certified to ISO9001 & ISO13485 Quality Management System for Medical
Device Manufacturers. Assessment and Certification is
provided by SGS Yarsley.
Electrical Safety & EMC
All
AtCor Medical products have been tested and approved
to the following Electrical Safety & EMC Standards:
IEC60601-1 Medical electrical
equipment Part 1:General requirements for safety
IEC60601-1-2
Medical electrical equipment –Part 1-2.
General requirements for safety- Collateral
standard: Electromagnetic compatibility-Requirements
and tests.
Test Reports can be supplied upon
request.
Regulatory
Australia
(TGA)
Products
are included on the Australian Therapeutic Goods
Register, ARTG Number 152313.
Europe
The SphygmoCor Cardiovascular Management Suite (CvMS) is
approved for import into the EU.
Classification: Class IIa
Directive: MDD 93/42/EEC
Assessment Route: Annex II
SGS MDD Certificate GB00/51436
EC Declaration of Conformity
EU Authorised Representative:
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Advena Ltd
Thorne Widgery House
33 Bridge Street, Hereford
HR4 9DQ, England, UK
Telephone:
+(44) 845 094 3307 Facsimile: +(44)
(0) 156 862 0078 |
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USA (FDA)
The SphygmoCor CvMS has FDA 510k-clearance
USA Agent Information
Doug Kurschinski
AtCor Medical Inc.
One Pierce Place, Suite 295-East
Itasca, IL, 60143, USA
Canada
The SphygmoCor CvMS product has a Medical Device License for
import into Canada.
China
The SphygmoCor CvMS has Chinese SFDA approval.
Korea
The SphygmoCor CvMS has a KFDA Medical Device Import Permit.
Japan
The SphygmoCor CvMS is registered with the MHLW in Japan.
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Quality Assurance
