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Download - MARTIKAN s.r.o. 018 02 Dolná Mariková 789, Slovak Republic has been assessed by 3EC International and found to be in conformance with the following standard! EN ISO 13485:2016 for

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Page 1: MARTIKAN s.r.o. 018 02 Dolná Mariková 789, Slovak Republic has been assessed by 3EC International and found to be in conformance with the following standard! EN ISO 13485:2016 for

Page 2: MARTIKAN s.r.o. 018 02 Dolná Mariková 789, Slovak Republic has been assessed by 3EC International and found to be in conformance with the following standard! EN ISO 13485:2016 for

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OWEN P. MARTIKAN (CA Bar #177104)...OWEN P. MARTIKAN (CA Bar #177104) [email protected] CHRISTINA S. COLL (CA Bar #250712) [email protected] LEANNE E. HARTMANN (CA Bar #264787)

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Slide 1 of 30 ISO 13485:2016 - Medical Devices Group...•ISO 13485:2003 –4 instances of the word “risk” •ISO 13485:2016 –32 instances of the word “risk” “13485 Plus”

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ISO 13485 - International Organization for Standardization · PDF fileISO 13485 ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes,