Ways to Report Medical Device Incidents in Australia via the MDIR System
Stop worrying about enforcing a safety culture! A safety culture can be built by constantly making people aware of reporting regulations and…
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The US FDA Medical Device User Fee for the Fiscal Year 2022
What do the applicants of 510(k) or other regulatory applications or companies looking to register or import need to pay? The FDA…
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ISO 15223-1:2021 Medical Device Symbols – An indispensable part of labeling
As we all know that symbols play a very important part in medical device labeling, hence it is critical to know when…
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BS EN ISO 13485:2016/A11:2021
Medical devices – Quality management systems – Requirements for regulatory purposes The release of the 2021 Amendment of ISO 13485:2016 has created…
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Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19
What are UV light-emitting products? UV light-emitting devices are devices that are manufactured, distributed, or used to control, destroy or deactivate viruses,…
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What does CE Marking imply and why is it required?
Manufacturers must obtain CE marking for the products they want to sell in the European Union (EU). When a product is CE…
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FDA’s New Requirements: What the MR based Medical Device Manufacturers need to know
For a manufacturer of medical devices placed in a Magnetic Resonance (MR) environment, it is important to show compliance with the applicable…
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ISO 20417:2021
Medical devices – What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021…
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The A, B, C of Clinical Trials for Medical Devices
Several medical devices undergo clinical trials on an ongoing basis. Typically, medical devices are categorized based on their invasiveness, intended purpose, risks,…
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