MEDICAL DEVICES DIRECTIVE 93/42/EEC
ISO 13485 MEDICAL DEVICES STANDARD
CE MARKING REQUIREMENTS
This Medical Devices Directive derives from EU Law and identifies the system controls and corresponding responsibilities imposed on Medical Device manufacturers supplying the European marketplace.
The Directive encompasses "Design critical criteria" and establishes routes for conformity assessment based on individual device complexity.
SO/TS 29000: ISO 9001 APPLICATION TO THE PETROCHEMICAL & GAS INDUSTRIES
AS 9100 & AS/EN 9120: ISO 9001 APPLICATION TO THE AVIATION INDUSTRY & AVIATION SUPPLY CHAIN
2K TEAM INCLUDES SBAC APPROVED AS/EN 9120 CERTIFIED SYSTEM AUDITORS.
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