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December 2021 : FSN : QIAcube Connect MDx Instrument REF 9003070 - issue with the text contained within several protocols which run on the QIAcube® Connect MDx instrument.
Dikunjungi: 11364
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.
Dikunjungi: 4336
December 2021 : Field Safety Notice ICSMA-21-343-01 - SSO Password Vulnerability for Cardiology Products : Unauthorized access to application functions and patient data
Dikunjungi: 4582
December 2021 : Initial Reporting FA 21072 : Field Safety Notification on AU/DxC AU Magnesium - IFU update due to lipemic interference for the Magnesium serum application failed to meet the performance specification.
Dikunjungi: 7274
November 2021 : Customer Safety Information (CSI) for Field Safety Corrective Action FCA AX077/21/S | FSN AX078/21/S, AX081/21/S : ComboBox does no longer login automatically after several reboots. Calculation of Cardiac Output (Thermodilution method) on
Dikunjungi: 6990
November 2021 : FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.
Dikunjungi: 11920
November 2021 : FCA Notification - iDesign Advanced Wavescan Studio System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 8914
November 2021 : FCA Notification - CATALYS™ Precision Laser System : Patch installation due to potential cybersecurity vulnerability concerning the Windows Print Spooler Service.
Dikunjungi: 12328
November 2021 : Initial Report for CR-2021-IGT-BST-011 (FCO72200484) - Leakage of cooling fluid of flat detector in the R-cabinet ®
Dikunjungi: 12129
November 2021 : FA1197 Abre Venous Self-expanding Stent System IFU Update
Dikunjungi: 4754
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Home
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Hubungi Kami
Carta Organisasi
Code of Ethics and Conduct
Board of Directors
Top Management
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Kajian Kepuasan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Laporan Tahunan
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