Sofia Nordgren, our Chief Compliance and Regulatory Officer (CCRO) and Director of Regulatory Affairs, was spreading the knowledge about how to ensure maximum returns from investigation initiated studies at the Medical Device Investigator Initiated Study Meeting in Brussels today. The presentation was about:
• Setting guidance protocols for conducting investigator initiated studies
• Evaluating potential pitfalls in investigator led studies
• Using past performance experience led benchmarks to assess outcomes of studies and steer outcomes towards success
• Strategic control over the outcome of the study to ensure maximum returns
• How investigator initiated studies can support regulatory claims and ensure compliance
Thank you for the opportunity MedtechIIS!