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One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new ...
The EU regulators delayed implementation of the EU MDR by a year with its new date of application now being May ...
Web-applications: These are simple computing tools that are designed and built for solving human problems and ...
Uterine fibroids are a diagnosis that many women receive every day, however, it is a diagnosis that women often ...
In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and ...
In this whitepaper, we will explore how to best utilize CAPAs in the medical device industry including best ...
The European Commission published a new guidance document that clarifies certain requirements originally outlined ...
Nanotechnology is the science of understanding, inventing, and controlling objects which are built in the scales ...
No matter what your product is, at some point in your regulatory journey you will need to appropriately determine ...
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct ...
Health Canada released a notice for the stakeholders of the medical device and drug industry to help them ...
Biosimilars are biological products that are composed or produced in living systems such as yeast or bacteria. ...
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