Qualityze - Blogs

In March 2025 the FDA stamped Boston Scientific’s Accolade pacemaker recall as Class I—the most serious catego...

Every batch of tablets, vials, or capsules you see on the market comes with a paper—or increasingly digital—tr...

Imagine walking into a hospital where everything runs seamlessly: minimal waiting times, clear communication, ...

Supply chains are the backbone of today’s global economy—but as they grow more complex, so do the risks and ex...

Every year, billions worldwide rely on healthcare systems for everything from routine check-ups to life-saving...

When you visit a doctor and get lab tests, the accuracy of those results isn’t just important—it’s crucial. Im...

Organizations with a mature safety culture understand that Job Safety Analysis (JSA) is not just a documentati...

One poorly chosen verb in a product label can land you into an FDA “refuse-to-accept” letter, a re-run of clin...

ICH E6 R3 demands that critical-to-quality risks, digital data flows, and consent clarity are baked in — not p...

For medical device, pharma, or biotech companies, product design is not an engineering exercise, but a complia...

Have you ever received a faulty component from a supplier and wondered how to fix and prevent it from happenin...

Under comprehensive GMP regulations, only a well-built QMS can assure consistent drug safety and quality. Thin...