How to get some help from Medical Device Regulators with Cliff Bleustein
In this episode, Cliff Bleustein, President and CEO of Apos Therapy is explaining to us all the process that his company followed to place his Medical Device on the market.
One of the most important advice was to get support from the regulators. They are the most reliable source of information so you can go in the right direction. FDA is providing this possibility to meet regulators and then be able to receive some feedback. This saves time and money for the company but also to the regulators.
Cliff explains to us also the way medical device companies can get Clinical Data for its product. Learn more about Apos Therapy with the links below.
Who is Cliff Bleustein?
Dr. Clifford Bleustein is the Global President and CEO of AposTherapy. Prior to AposTherapy, Dr. Bleustein was President and CEO of Computer Task Group (NASDAQ: CTG) where he managed more than 3400 people globally and more than $340M in revenue across healthcare, technology services, energy, and financial services with operations in North America, Western Europe, and India. Dr. Bleustein went to CTG from Dell where he had several roles rising to become the Chief Medical Officer and Global Healthcare Solutions Leader with P&L responsibility for Healthcare & Life Sciences Solutions globally.
Doctor Bleustein also had a successful period as a consultant at PwC rising to Director with a diverse experience of projects including interim executive director of outpatient services, business strategy, international “biocluster” development, mergers & acquisitions, healthcare operations, physician alignment, governance, and resource optimization. On the ground experience in the UK, Ireland, India, South Africa, and China with assessments in the Middle East / Asia.
Clifford Bleustein graduated from the Medical College of Wisconsin and completed his internship at the New York Hospital Medical Center of Queens. Cliff later completed his residency in urology at Montefiore Medical Center. Then he went on to private practice Urology and became a board-certified Urologist. He has an extensive roster of peer-reviewed published research and 2 patents. Dr. Bleustein earned a bachelor’s degree in science from the University of Wisconsin, Madison. He also received an executive master’s degree in business administration from NYU Stern School of Business where he now teaches Healthcare Economics as an Adjunct Professor.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links from the Video
- Cliff Bleustein LinkedIn: https://www.linkedin.com/in/cbleustein/
- Apos Therapy Website: https://www.apostherapy.com/
- Episode 58 – How to register medical devices through 510k: https://podcast.easymedicaldevice.com/58/
