Quality managers everywhere will attest to the fact that effective document control is critical to t...
Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requi...
Many executives only see internal audits as something that has to be done for compliance reasons. Ho...
According to a recent survey by the Independent International Organization for Certification (IIOC),...
Many startups mistakenly believe that creating a successful QMS strategy means building complex solu...
Medical devices undergo a strict and rigorous evaluation by the Food & Drug Administration (FDA) to ...
The saying "an ounce of prevention is worth a pound of cure" is especially applicable when talking a...
Maintaining oversight and control of your supply chain is a critical part of your organization's qua...
As product developers work to bring new concepts to reality, a regulatory affairs professional shoul...
Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vin...