Certification/Licensing

Certified safety

 

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 9000Quality Management Systems – Fundamentals and definitions 
 
DIN EN ISO 13485        Quality Assurance Systems – Medical products - Requirements for regulatory purposes 
 
93/42/EWG

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

 
EN ISO 14971Medical products – Application of risk management 
 
MPG Medical Devices Act (Implementation of guideline 93/42/EWG in Germany)  
 
DIN ISO 2859, Part 1Sampling procedures for inspection by attributes 
  
MDSAPMedical Device Single Audit Program
 
FDA Regulation

Quality System 21CFR Part 820 Quality Systems Regulation