Archive for February 2024

On this episode of the SSI Executive Conversations podcast, Darwin hosts Dr. Margaret Kalmeta, the CEO/Founder of Rapid Nexus Nano-Tech Wound Technology, a cutting-edge wound care Medtech organization. On this insightful episode, Darwin and Dr. Margaret talk about a multitude of topics including wound care solutions, executive leadership, hiring for culture, where the industry is…

In this episode, we dissect critical insights, including the need to avoid a transactional approach in regulatory processes and the importance of strategic planning to mitigate risks. The podcast sheds light on the high rate of FDA rejections for 510K applications and emphasizes the significance of emotional intelligence in regulatory professionals for successful submissions. Furthermore,…

Robert has a wealth of experience in authoring successful submissions and leading teams through oversight and strategy. We explore the vital role Regulatory should play in the C-Suite and how it can influence strategic decisions for efficient growth and risk mitigation. To visit Robert’s LinkedIn page click here.

Kevin Posey is a Subject Matter Expert in MedTech RA/QA with over 25 years of experience, working at companies ranging in size. In this episode, Darwin and Kevin talk about resource/responsibility management at small vs. big companies, The strategic importance of RA/QA, and the value of developing high emotional intelligence to communicate with governing bodies…