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Labeling for medical devices is under strict regulations. The requirements are dependent on the class ...
Developing a Design and Development Plan is a part of the design controls process required by the FDA ...
Manufacturers may find themselves without the resources and processes needed to effectively and ...
A Non-Conforming Material Report or NCMR is the standard way to report a material that does not meet the ...
On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo ...
When registering a medical device with the FDA the type of product influences the method of pre-market ...
The idea behind the management review process is to take a step back from the day-to-day operating of ...
One of the more ambiguous parts of the Quality System Regulations, 21 CFR 820, is making judgments ...
Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow ...
A Quality Management System (QMS) is often designed well before a company starts the development of its ...
For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) ...
An internal audit program is vital for proper monitoring and assurance of products. It is also ...
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