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Medical Directives Requirements & Harmonised Standards R&D Planning – AMPQ Risk Management ISO 14971 Product – Process Safety GMP – GDP Technical File & CE marking Quality Management ISO 13485 MEDICAL DEVICES IN-VITRO DIAGNOSTICS Head Office Allanta vzw HASSELT H. van Veldekesingel 150 bus 58 B-3500 Hasselt Tel.: +32 (0)11.870 944 Fax: +32 (0)11. 870 801 OPLEIDING – BEGELEIDING - COACHING Met Allanta uw design en ontwikkeling in één keer goed www.allanta.eu [email protected]

LifeTechLimburg Interregio 05102011_ pitch Allanta

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Page 1: LifeTechLimburg Interregio 05102011_ pitch Allanta

Medical Directives

Requirements & Harmonised Standards

R&D Planning – AMPQ

Risk Management ISO 14971

Product – Process Safety GMP – GDP

Technical File & CE marking

Quality Management ISO 13485

Medical Vigilance - CAPA

MEDICAL DEVICESIN-VITRO DIAGNOSTICS

Head Office Allanta vzw HASSELTH. van Veldekesingel 150 bus 58B-3500 HasseltTel.: +32 (0)11.870 944Fax: +32 (0)11. 870 801

OPLEIDING – BEGELEIDING - COACHING

Met Allanta uw design en ontwikkeling in één keer goed

www.allanta.eu [email protected]