• CE Marking Technical Guidance & Consulting
  • Medical Device Technical File / Design Dossier preparation
  • Risk Analysis support as per ISO 14971
  • Post Market Surveillance ( PMS)
  • Post Market Clinical Follow Up ( PMCF)
  • Clinical Evaluation as per MEDDEV 2.7/1 revision 4
  • Biocompatibility Testing As per ISO 10993-1 series
  • Safety Testing as per IEC 60601-1 series and other Harmonized standards
  • Performance Testing
  • Notified Body Selection and Coordination till issue of Certificate
  • EU Representation
  • Free Sale Certificate.


 
 

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