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It is common knowledge that supplier quality is a critical piece of any MedTech QMS. No matter which regulatory ...
The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away ...
If you have developed a medical device, you know how important the concept of traceability is. Every facet of the ...
FDA played a key role in the negotiations of the United States-Mexico-Canada Agreement. The agreement entered into ...
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 EU
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 know
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. ...
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