EU Medical Device CE Mark Consulting and CE Mark Consultants

EU Medical Device CE Mark Consulting Services

FDA Consultant

Dr. David Lim | CE Mark Consultant

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (Regulatory Doctor LinkedIn Google Plus Twitter Facebook Tumblr)

We provide a full package of CE mark services including, but are not limited to, the following.

  • 360 View and Consulting: Advice, Guidance and Direction
  • Medical Device Directives
    • EU Medical Device Directive (MDD)
    • In Vitro Diagnostic Directive (IVDD)
    • Active Implantable Medical Device Directive (AIMD)
  • Device Definition (MEDDEV 2. 1.1 and MEDDEV MEDDEV 2. 1.3 rev 3)
  • Device Classification (MEDDEV 2.4/1 rev.9)
  • Notified Body
  • Technical File
  • Design Dossier Preparation
  • STED
  • Harmonized Standards under MDD, AIMDD, and IVDD
  • Quality System Management (QMS) for Medical Devices
  • Current Good Manufacturing Practice (cGMP) for Medical Devices
  • Medical Device Labels and Labeling
  • Mock Audit and Inspection Preparation
  • EN ISO 13485:2012
  • EN ISO 14971:2012
  • ISO 14155
  • Clinical Evaluation
  • Clinical Investigation
  • Guidance MEDDEVs
  • Other Various Standards

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Learn about Dr. David Lim's LIVE Webinars on FDA Compliance Matters

Learn about LIVE seminar/webinar on CE Marking.

Last Date Updated: December 6, 2014