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...
A supplier audit is one of the most effective ways to ensure your suppliers adhere to quality standa...
Internal audits are an essential part of quality management. Working with external auditors ensures ...
Companies selling medical devices or pharmaceuticals are required by applicable regulations and stan...