Resource Center
Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
Sort by topic
Sort by resource type
A lot of work goes into a 510k submission for a medical device. Companies that submit a 510k for a ...
CBD has been growing more and more popular in the US, both in medical products and in products for ...
Cervical Cancer is the fourth most common cancer in the world in women[1]. Nearly all cases of cervical ...
For a medical device that comes into contact with a person’s skin, biocompatibility testing is required ...
The design and development process is long and challenging. At the end of the process comes what is ...
Cervical cancer is something that every woman has to be concerned about. More common in women over the ...
One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD ...
As 2021 has come to a close and companies are holding and finalizing their last management reviews, ...
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 ...
Ready to learn more about working with us?
