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Medical Device and FDA Regulations and Standards News

Discussions
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Significant change notice for outsourced warehouse
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Learner 10
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Medical device country of origin
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Ronen E
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Automated Dispensing Machines Market Demand, Sales and Growth Opportunities
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21
PramodKumar
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Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
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80
Ronen E
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Informational Critical Thinking and the Process of Evidence-Based Practice
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70
Marcelo
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Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands
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66
Marcelo
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Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands
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68
Marcelo
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Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means
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80
Marcelo
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Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices
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56
Marcelo
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Informational Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)?
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78
Marcelo
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Informational EU – Official position on EUDAMED delay
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116
Marcelo
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Informational TGA presentation: Cybersecurity for medical devices
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48
Marcelo
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Informational TGA presentation: How to submit an effective good manufacturing practice clearance application
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49
Marcelo
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Informational BSI UK notified under the IVDR
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83
Ronen E
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Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra
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47
Marcelo
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