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)

MDSAP	Medical Device Single Audit Program

FDA Regulation	Quality System 21CFR Part 820 Quality Systems Regulation