Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.

In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance.

While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.

In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential.

Everyone has their own favorite graph type or visual tool. I’m not ready to declare this my favorite yet, but this oldie but goodie has got to get more time and attention.

_‘Clinician burnout is a critical issue to understand and address,” says Mohsen Bayati, a professor of operations, information, and technology at Stanford Graduate School of Business. The condition is thought to affect nearly half of all U.S.

Cybersecurity has become increasingly critical in the digital age as organizations across all sectors face growing threats from cybercriminals.

Before the ICH Harmonized Tripartite Guideline Q9—“Quality risk management”—was introduced in 2005, the pharmaceutical industry was evolving but lacked a structured, scientific, and systematic approach.

With its roots in compassion and humanity, the healthcare sector might seem an unlikely place for artificial intelligence (AI) to play a big role.

The U.S. Food and Drug Administration (FDA) is the country’s chief agency for regulating the manufacture, marketing, and distribution of critical consumer goods including food, cosmetics, medical devices, biological products, and pharmaceuticals.