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Sharan Murugan
- Jul 6
- 2 min
TGA Guidance: Regulatory Changes for Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...
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Sharan Murugan
- Jul 6
- 2 min
MDCG Med Dev Guidance: Standardisation for Medical Devices
The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...
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Sharan Murugan
- Jul 3
- 2 min
Swissmedic Guidance: Formal Requirements and SwissPAR
The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....
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Sharan Murugan
- Jul 3
- 2 min
ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...
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Sharan Murugan
- Jul 3
- 2 min
IMDRF Guidance: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...
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