An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.

Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.

In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.

At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there.

Technology has reshaped the healthcare industry, empowering clinicians, technicians, and executives to better serve patients and achieve their goals. However, technology doesn’t eliminate the need for human oversight and management.

Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.

So far in this series our focus has remained on statistical process control (SPC) in manufacturing.

Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process.

Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good grasp of them makes the process less confusing.

Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets.