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HAZARD ANALYSIS and RISK MANAGEMENT  EN 14971............more...........

DESIGN CONTROL - Do you need assistance to Implement effective Design Control?...more...

COMPANY and PERSONAL PROFILE.....over 30 years in the Healthcare Industry and vast Auditing experience............more..... 

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We can also assist accomplishment with any of the following;

ISO 13485:1996 / EN ISO 13485:2001 / ISO 13485:2003 / MDD 93/42/EEC / IVD 98/79/EC - European Requirements, Canadian TPD Requirements, Australian TGA Requirements or FDA 21 CFR 820 QSR Requirements.......more......

ISO 13485 for manufacturers of medical devices........more......

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