REGULATORY EXPERTISE

US Food and Drug Admininstration

Canada - Health Products and food Branch Inspectorate

United Kingdom - Medicines Control Agency

Ireland - Medicines Board

Switzerland - Swissmedic

Japan - Ministry of Health, Labour, and Welfare

Singapore - Health Sciences Authority

ISO9001 and ISO 13485

Canadian Medical Device Regulations (SOR/98-282)

EU Medical Device Directive 93/42/EEC

RESULTS & BENEFITS

Reduced operator errors and deviations

Integrated SOP attachment information placed at the point of use

Production dossier readied for electronic batch records (EBR)

Paperwork integrity matches the process

Embedded compliance with industry and government regulations (including FDA 21 CFR Part 11)

Improved traceability