Nanna Finne

If you work QARA in medical devices or pharma, you know that CAPAs aren’t just paperwork - they’re at the heart of compliance and audits. That said, writing CAPA reports that hold up under inspection can be tricky.

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS...

Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...

As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is officially in force. The FDA’s new Quality Management System Regulation (QMSR) represents the most significant overhaul of U.S. medical device quality requirements in mo...

A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation...

GMP stands for “good manufacturing practices.” Life sciences companies need to be GMP-certified in order to produce and sell their products. But what do GMP guidelines entail? And how is GMP different from cGMP, or “current good manufacturing practic...

Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...