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One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing ...
Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur ...
Contract Manufacturing Organizations, CMOs, have become commonplace in the life sciences industry. ...
The FDA conducts Pre-Approval Inspections (PAI) to assure that a facility can manufacture the intended ...
The FDA defines validation as a process required to establish documented evidence that provides a high ...
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising, ...
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a ...
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a ...
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices ...
Medical devices have advanced beyond the point of simple machinery. Software has begun playing an ...
A fundamental question in any drug development program is which regulatory pathway to pursue. There are ...
Suppliers play a pivotal role in life sciences companies. Whether they are providing a company with ...
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