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.

510K Submission Tips

510K Submission Tips

‌  Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow ...
Making a Change to a QMS

Making a Change to a QMS

‌  A Quality Management System (QMS) is often designed well before a company starts the development of its ...
What to Do with a Bad QMS

What to Do with a Bad QMS

‌  For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) ...
Making a Design History File

Making a Design History File

‌  A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for ...
The FDA and CBD

The FDA and CBD

‌  As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer ...
Choosing a Predicate Device

Choosing a Predicate Device

‌  One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing ...
Audit Readiness

Audit Readiness

‌  Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur ...
Choosing the Right CMO

Choosing the Right CMO

‌  Contract Manufacturing Organizations, CMOs, have become commonplace in the life sciences industry. ...

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