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
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 ...
A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for ...
During the early stages of a drug’s preclinical development, after a product is identified as a viable ...
As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer ...
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 ...
Ready to learn more about working with us?
