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Certification/Licensing

The Quality Management and Environmental Management systems of STOCKERT GmbH, together with the accompanying handbooks, are based on and include the consideration and implementation of guidelines and definitions taken from all of the following Standards:

 

DIN EN ISO 13485        Quality Assurance Systems – Medical products - Requirements for regulatory purposes 
  
93/42/EEC

Annex II – EC Declaration of Conformity (Complete QA System)

  
MDSAPMedical Device Single Audit Program
  
FDA Regulation

Quality System 21CFR Part 820 Quality Systems Regulation