QAdvis is now officially part of Aurevia. This change of name follows our company’s integration into Aurevia. The Aurevia brand was born in January, when Labquality, Artimed, Clinical Consulting, Kasve, and Prisma CRO merged under the same name. With QAdvis now proudly joining the team, we are further strengthening our expertise and services and together offering greater value to our joint customers. Scandinavian CRO is also joining Aurevia.
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact of this evolving approach. Importantly, the same strategies that help mitigate risks under increased transparency also serve to strengthen the likelihood of a successful submission. Given the FDA’s growing emphasis on […]
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but later approved. While this “radical transparency” currently applies only to pharmaceuticals, it may signal what’s ahead for medical devices. As of July 2025, the U.S. Food and Drug Administration (FDA) has […]
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International Standard (FDIS) was published earlier this spring, and the voting was closed the July 17. The standard was approved and is now under publication. What’s changing? The new version of […]
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Under the EU MDR, a structured, proactive approach with strong links to risk management and authority dialogue is essential. PMS has become a cornerstone of regulatory work under EU MDR 2017/745 and IVDR 2017/746. […]
In the competitive and highly regulated world of medical technology, a robust and well-structured Design and Development (D&D) process is not just a best practice—it is a business-critical necessity. From concept to commercialization, a robust D&D process lays the foundation for safety, compliance, efficiency, and innovation. Below, we explore why medical device companies must prioritize […]