13485問卷調(diào)查表-在線瀏覽
2024-09-03 01:32本頁面
【正文】 with Annex II適用于第IIb和III類醫(yī)療器械及不需按附件II要求Annex IV (EC Verification) 附件IV（EC驗證） Please define proposed scope of SGS registration for these standards, if applicable. 適當時詳細說明以上標準的認證審核的范圍ISO 9000: 2000ISO13485: 2003 Please add any other QMS certification to be included in this proposal (. ISO 14001, BRC CP, etc)請?zhí)砑尤魏纹渌ＭJ證的體系（例如。（僅供參考）EU歐洲USA 美國Canada加拿大Australia/New Zealand 澳大利亞/新西蘭Japan日本PRC (China) 中國大陸ROC (Taiwan) 中國臺灣Other Asian Countries其它亞洲國家Russian States俄羅斯 Near/Middle East 中東Africa 非洲South America南美 Processes 過程Do you undertake design activities at the registration address?在注冊的地址是否從事產(chǎn)品的設(shè)計活動YesNoDo you design puter software (. to control your devices)?產(chǎn)品設(shè)計中是否包括設(shè)計計算機軟件 （例如用于控制醫(yī)療器械）YesNoIn what language(s) are the design and regulatory documents available? 設(shè)計和法規(guī)文件是什么語言？Is you technical documentation plete, if not when do you expect it will be?技術(shù)文件是否已完成？如果沒有完成，預(yù)計什么時候能完成？YesNoDo you undertake any operations within a controlled environment or cleanroom?是否有在受控環(huán)境和潔凈室完成的任何操作？YesNoIf YES, please give details 如果有，請詳述細節(jié)Are some of your products supplied by you sterile? 您是否有提供消毒的產(chǎn)品？YesNoDo you operate sterilization processes? 貴公司是否有滅菌過程？YesNoIf YES, please give details of the type of processes 如有,請描述滅菌過程的類型Do you use a sterilization subcontractor? 是否有滅菌的分包方?YesNoIf YES, please give name and type of process and a copy of any ISO 13485 certification. 如果有，請給出滅菌過程的名稱和類型以及其ISO13485證書的復(fù)印件Are there any other critical operations or services carried out by a sub contractor? 是否有其它由分包方承擔(dān)的關(guān)鍵性操作或服務(wù)YesNoIf YES, give details and a copy of the certification where possible.如果有，可能情況下提供證書復(fù)印件及下列詳情：Company公司Activity活動Standard標準Certification Company認證公司
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