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News

February  2007

LNE/G-MED is involved in the Pilot Multipurpose Audit Program (PMAP) :

LNE/G-MED is involved in the Pilot Multipurpose Audit Programm (PMAP) developped by FDA (USA) and Health Canada. LNE/G-MED can be requested by medical devices manufacturers to carry out simultaneously :

• audit according to ISO 13485:2003 and related provisions of the Canadian Medical Devices Regulations
• inspections according to the U.S. Quality System Regulations 21 CFR Part 820

For more information, please consultHealth Canada and FDA websites.