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Page 1: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 2: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 3: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 4: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 5: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 6: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 7: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 8: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 9: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 10: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 11: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 12: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 13: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 14: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 15: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 16: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry
Page 17: tiua.instrument.org.twtiua.instrument.org.tw/archive/file/1080906001.pdf · Premarket Submission Recommendations for Interoperable Medical Device, 2017. US FDA: Guidance for Industry