Product Service CERTIFICATE No. Q1N 150674222005 Holder of Certificate: Creagh Medical Ltd IDA Business Park Balinasloe, Co Galway IRELAND Facility(ies): Certification Mark: Scope of Certificate: Creagh Medical Ltd IDA Business Park, Balinasloe, Co Galway, IRELAND Design, development and production of PTA and PTCA devices for the vascular System Applied Standard(s): EN ISO 13485:2012 +AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009) DIN EN ISO 13485:2012 The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). See also notes overleaf. Report No.: 75930237 Valid from: Valid until: 2015-08-01 2018-07-31 Date, 2015-07-20 Page 1 of 1 Hans-Heiner Junker (( DAkkS Deutsche Akkreditierungsstelle D-ZM-11321-01-00 TUV SUD Product Service GmbH • Zertifizierstelle • RidlerstraRe 65 • 80339 Munchen • Germany TOV*
Transcript
Product Service
C E R T I F I C A T ENo. Q1N 150674222005
Holder of Certificate: Creagh Medical LtdIDA Business ParkBalinasloe, Co GalwayIRELAND
Facility(ies):
Certification Mark:
Scope of Certificate:
Creagh Medical LtdIDA Business Park, Balinasloe, Co Galway, IRELAND
Design, development and production ofPTA and PTCA devices for the vascularSystem
AppliedStandard(s):
EN ISO 13485:2012 +AC:2012Medical devices - Quality management systems -Requirements for regulatory purposes(ISO 13485:2003 + Cor. 1:2009)DIN EN ISO 13485:2012
The Certification Body of TUV SUD Product Service GmbH certifies that the company mentionedabove has established and is maintaining a quality management system, which meets therequirements of the listed standard(s). See also notes overleaf.
TUV SUD Product Service GmbH • Zertifizierstelle • RidlerstraRe 65 • 80339 Munchen • Germany TOV*
ZertifiziervertragGrundlage fur die Zertifikatserteilung ist diePruf- und Zertifizierordnung von TOY SUDProduct Service.
Mit Erhalt des Zertifikates erkennt derZertifikatsinhaber die jeweils gultige Fassungder Pruf- und Zertifizierordnung an(www.tuev-sued.de/ps__regulations) und wirdsomit Partner im Zertifiziersystem vonTUV SOD Product Service.
Prinzipieiie Voraussetzung fur die Gultig-keit des Zertifikates:
- Gultigkeit der zitierten normativen Pruf-grundlage(n) ist gegeben
und zusatzlich bei Zertifikaten mit Berechti-gung zur Verwendung eines Prufzeichensbzw. bei Zertifikaten fur QM-Systeme:
- Voraussetzungen fur vorschriftsmaRigeFertigung werden eingehalten.
- Die Fertigungs- bzw. Betriebsstatten wer-den regelmaftig uberwacht.
Certification contractCertification is based on the TOY SODProduct Service Testing and CertificationRegulations.
On receipt of the certificate the certificateholder agrees to the current version of theTesting and Certification Regulations(www.tuev-sued.de/ps_regulations) and thusbecomes partner in the TOY SOD ProductService Certification System.
Requirements for the validity of the certi-ficate in principle:
- Validity of the quoted test standard(s)
In addition for certificates with the right to usea certification mark and for QM certificates:
- Conditions for an adequate manufacturingare maintained
- Regular surveillance of the facility is per-formed
Low Voltage Directive 2006/95/ECToys Directive 2009/48/ECDirective for Active Implantable Medical Devices 90/385/EECDirective for Medical Devices 93/42/EECDirective on In Vitro Diagnostic Medical Devices 98/79/ECDirective for Gas Appliances 2009/142/ECDirective for Personal Protective Equipment 89/686/EECEMC Directive 2004/108/ECDirective for Recreational Craft 94/25/EC + 2003/44/ECDirective for Machinery 2006/42/ECDirective for Ex Safe Equipment 94/9/EC
ENEC Agreement for luminaires, household and IT equipment
USA• Nationally Recognized Testing Laboratory (NRTL) to 29 CFR
1910.7byOSHA
• Accredited for FDA 510(k) Third Party Review
• Conformity Assessment Body to the MRA for MedicalDevices; FDA QSReg Inspections, FDA 510(k) Third PartyReview
Asien-Pazifik Region / Asia Pacific• Recognized Certification Body to Electrical Products (Safety)
Regulation; Hong Kong
• Konformitatsbewertungsstelle / Conformity Assessment Bodyto the MRA for Medical Devices; Australien / Australia
• Konformitatsbewertungsstelle / Conformity Assessment Bodyto the MRA for Medical Devices; Neuseeland / New Zealand
Weltweit / Worldwide• NCB im CB-Scheme des IECEE /
NCB in the CB Scheme of IECEE
• ExCB im lECEx-Scheme des IECEE /ExCB in the lECEx Scheme of IECEE
• Zertifizierstellen durch DAkkS akkreditiertDE-ZE-11321-01, DE-ZM-11321-09 und DE-ZM-11321-01.Certification Bodies accredited by DAkkSDE-ZE-11321-01, DE-ZM-11321-09 and DE-ZM-11321-01.
Zertifizierstelle fur Produkte / Certification Body for Products • e-mail [email protected] fur Medizinprodukte / Certification Body for Medical Devices • e-mail [email protected] / Clients Services • Phone +49/89/50 08-42 61 • Fax +49/89/50 08-42 30 • e-mail [email protected]
