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Class III Medical Device CE Marking

Class III Medical Devices are critical devices and having higher risk compared to Class IIa and Class IIb type of Medical devices. Class III Medical Devices require, Product testing, Quality system implementation (ISO 13485) Techinical file preparation, Notified Body audit and Certification.

Class III Medical Device - Examples

  • Pacemaker
  • Absorbable Suture

CE Classification may change depends on the intended use, please check with MDD 93/42/EEC ANNEX IX for your device classification.

LMG can assist you with

  • Medical Device Classification
  • Identification of MDD requirements
  • Identification of Harmonized standards
  • ISO 13485 Implementation
  • Identification of Notified Body
  • Technical File preparation
  • Technical File submission to Notified Body
  • Technical file re-submission
  • Assistance with Notified Body audit
  • Assistance in closing non-conformities
  • Affix CE Mark

 
LIBERTY MANAGEMENT GROUP LTD.
75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@libertymanagement.us