Medical Device Classification Under MDR & IVDR: What Manufacturers Need to Know

Why Medical Device Classification Matters If you’re a medical device or in vitro diagnostic (IVD) manufacturer, one of the first regulatory hurdles you’ll face is classification. This might sound like a technicality, but getting it right is crucial—it determines how much regulatory oversight your product needs, how long it will take to get to market, […]

Why Less is More in Clinical Data – Insights from Senior Clinical Data Manager Åsa Testad

Åsa Testad’s career began with a background in informatics and programming—skills that today serve as the foundation of her work in clinical studies. After entering the field in the late 1990s, Åsa transitioned into data management and found a role that combined problem-solving, structure, and collaboration. “My role involves working at the intersection of different […]

Navigating IVDR Certification: Prostatype’s Success Story with GBA Key2Compliance

Prostatype Genomics is at the forefront of precision medicine, offering the Prostatype® test—a groundbreaking genetic diagnostic tool designed to assess the aggressiveness of prostate cancer. By providing crucial insights, Prostatype helps clinicians and patients make informed treatment decisions, ultimately improving patient care and optimizing healthcare resources. Prostatype has an ability to significantly improve the quality […]