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A critical, yet often overlooked, part of bringing your medical device to market is ensuring it complies with all ...
Now that the world is done dealing with the Brexit drama, there is more on the plate for the EU Commission.
The ...
The 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C ...
Today marks the 52nd anniversary of the birth of the true modern environmental movement, however, you probably ...
2021 is shaping up to be a big year for MedTech mergers and acquisitions. Last week, Siemens Healthineers and ...
FDA launched the ASCA Pilot on September 25, 2020. This pilot would grant ASCA recognition to qualified ...
The mission of the Food and Drug Administration is to protect public health by ensuring compliance of products and ...
On April 2nd, 2021, the FDA provided an update on its Pandemic Preparedness and Recovery Plan (PREPP) Initiative. ...
Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID ...
Human Factors Engineering is a major component of the Design Controls process for Medical Devices. Understanding ...
Following the US FDA and now the EU Commission’s EUDAMED, Australia’s Therapeutic Goods Administration (TGA) also ...
The Accredited Persons (AP) Inspection Program allows for accredited persons to conduct the equivalent of an FDA ...
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