The medical device industry is growing. Data from KPMG predict that global annual sales will rise by 5% per year to reach just under $800 billion by 2030.

Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.

Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide.

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.

Back in 2023, only 15% of businesses had adopted AI-augmented software testing tools. By 2027, that number is expected to leap to 80%.

ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS).

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.