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Extended MDR Date of Application: Optimizing your PMS and clinical activities
Now that the European Medical Devices Regulation (MDR) final date of application has been pushed to May 2021, medical device manufacturers should
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Combination products use errors white paper
Combination products: common use errors and design considerations
Combination products, such as injection devices, inhalers, nebulizers, and drug patches, are increasingly being used by laypeople for self-
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Combination products home injections
Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products
FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.
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Get smart about Australia in 1 hour
If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory
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Medical device registration in Australia and New Zealand
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
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What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
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