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.

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.

This year, the Medical Device Innovation Consortium held an Excellence in Quality Summit where it was promised that participants would receive a “uniq

In food processing, bulk-bag discharge systems are used to transfer food ingredients such as flour, sugar, and spices from bulk bags to mixing and blending equipment.