Qualitymanagement and Riskmanagement:

  • Introduction of DIN EN ISO 13485: 2016 and DIN EN ISO 9001: 2015
  • Introduction of a QMS according to FDA 21 CFR 820
  • Gap analysis
    • from DIN EN ISO 13485: 2012 to DIN EN ISO 13485: 2016 or FDA 21 CFR 820
    • from DIN EN ISO 9001: 2008 to DIN EN ISO 9001: 2015
    • from ISO / TS 16949 to DIN EN ISO 13485: 2016
  • Implementation of the risk management process according to DIN EN ISO 14971
  • Execution of internal audits and supplier audits
  • Standardcompliant documentation according to the cDMS system Leopold

 

Strategy and business expansion:

  • Consulting for doctors of medicine and Start-ups in the area medical devices
  • Support for the diversification in the healthcare sector
  • Consulting in the acquisition
  • Consulting on the acquisition of companies in the healthcare industry
  • SWOT analysis for companies under medical aspects
  • Strategy Development, Technical Due Diligence

Qualitäts- und Risikomanagement