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.
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices. In late September, the FDA finalized its guidance on Computer Software Assurance (CSA) for software used in medical device production and quality systems. Replacing Section 6 of the earlier “General Principles of Software […]
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, expert support is no longer a luxury—it’s a strategic necessity. “There has been a cultural shift in the industry,” says Ulrika Hammarström, Head of CRO Operations at Aurevia. “Expert support is now […]
In the third part of our article series on the FDA’s new “radical transparency” initiative, we explore strategic considerations for a successful 510(k) submission. As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness and coherence. Successfully navigating the FDA’s 510(k) pathway requires more than […]
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 […]