BILLEV PHARMA EAST

NEWS

17 June 2024

Billev Pharma East’s expansion into Medical Devices with Focus on Post-Market Surveillance

Billev Pharma East is continuously acquiring new knowledge in the medical devices field, reflecting our commitment to quality, innovation and excellence in healthcare solutions. As part of this growth, our committed staff continues to learn more about this important area and keep up with the most recent developments and legal requirements.

A key area of interest is post-market surveillance of medical devices, an essential component of ensuring their safety and efficacy. Recently, our team attended an insightful seminar hosted by IPI Academy titled “Post-Market Surveillance – Practical Application for Medical Devices and IVDs.” This seminar highlighted the importance of post-market surveillance and provided practical examples that attendees could apply in their work. Participants were encouraged to share their professional experiences, fostering a collaborative learning environment, and enabling the exchange of best practices.

One of the key takeaways from the seminar was the emphasis on important MDCG documents, specifically the guidance for Periodic Safety Update Report (PSUR) and Post-Market Clinical Follow-up (PMCF evaluation report and PMCF plan). These guidelines are crucial for maintaining compliance and enhancing the safety and performance of medical devices in the market.

Our commitment to continuous learning and adherence to industry best practices ensures that we remain at the forefront of the medical device sector. By integrating these valuable insights and guidelines, we are better equipped to deliver top-quality services, ultimately contributing to improved patient outcomes.