Transcription of MEDICAL DEVICE TECHNICAL SPECIFICATION - HSA
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MEDICAL DEVICE TECHNICAL SPECIFICATION TS-01: Good Distribution Practice for MEDICAL devices - Requirements Revision 01 SEPTEMBER 2012 MEDICAL DEVICE TECHNICAL SPECIFICATIONS SEPTEMBER 2012 HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Page 2 of 33 PREFACE This document sets out the requirements for the Good Distribution Practice for MEDICAL devices (GDPMDS). In the event of any contradiction between the contents of this document and any written law, the latter shall take precedence. MEDICAL DEVICE TECHNICAL SPECIFICATIONS SEPTEMBER 2012 HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Page 3 of 33 1.
medical device technical specifications september 2012 health sciences authority – health products regulation group page 3 of 33
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MANAGEMENT OF MEDICAL DEVICES, Medical, Software as a Medical Device, DuPont Medical, Technical, DuPont, Safety and Performance of Medical, Safety and Performance of Medical Devices, B COUNCIL DIRECTIVE 93/42/EEC, MEDICAL DEVICE REGULATION PRE-MARKET, MEDICAL DEVICE REGULATION PRE-MARKET APPROVAL, Medical Device, Nutrient Agar, Mueller Hinton Agar, EXAMPLE VALIDATION SPREADSHEET SERVING