Marc Bergenthal, B.Sc.

Experienced manager in the field of quality management and regulatory affairs with a focus on software, especially AI/ML and cloud solutions, including mobile devices. But medical devices in other categories, such as (sterile instruments) or electrical devices, are also not unknown.

Successful product approvals, including in the US market (“510(k) submissions”) as well as evaluations of technical documentation according to EU MDR. In addition, several companies have been supported in switching from the EU MDD to the EU MDR for certification.

Tested and certified by the “Regulatory Affairs Professionals Society” (RAPS), the world’s largest organization for regulatory affairs professionals in the healthcare sector: “Regulatory Affairs Certification” (RAC).