How can I get help from medical device regulators?

How can I get help from medical device regulators?

HomeEasy Medical DeviceHow can I get help from medical device regulators?
How can I get help from medical device regulators?
ChannelPublish DateThumbnail & View CountDownload Video
Channel Avatar Easy Medical Device2020-09-21 08:00:09 Thumbnail
242 Views
► Website: https://podcast.easymedicaldevice.com/94/

In this episode, Cliff Bleustein, President and CEO of Apos Therapy, walks us through the process his company went through to bring its medical device to market.

One of the most important pieces of advice was to get support from the regulators, they are the most reliable source of information to help you get in the right direction.

Cliff also explains to us how medical device companies can obtain clinical data for their product.
More information about Apos Therapy can be found via 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 led a global team of over 3,400 people and generated over $340 million in revenues in healthcare, technology services, energy and financial services with operations in North America, Western Europe and India. Dr. Bleustein joined CTG from Dell, where he held various roles, rising to Chief Medical Officer and Global Healthcare Solutions Leader with P&L responsibility for Healthcare & Life Sciences Solutions globally. Dr. Bleustein also enjoyed a successful stint as a consultant at PwC, rising to the position of Director with diverse experience in projects including interim executive director of outpatient services, corporate strategy, international “biocluster” development, mergers and acquisitions, healthcare operations, physician alignment, governance and resource optimization. Workplace experience in the UK, Ireland, India, South Africa and China with assessments in the Middle East/Asia.

Dr. Bleustein graduated from the Medical College of Wisconsin and completed his internship at New York Hospital Medical Center of Queens. He later completed his residency in urology at Montefiore Medical Center. He went on to open his own urology practice and became a board certified urologist. He has an extensive record of peer-reviewed published research and holds 2 patents. Dr. Bleustein earned a Bachelor of Science degree in Science from the University of Wisconsin, Madison. He also received an Executive Master of Business Administration from the 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 specializing in quality and regulatory issues. After working for many years in a large healthcare company, Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand medical device regulations worldwide. He has now founded the consulting company Easy Medical Device GmbH and developed many ways to share knowledge through videos, podcasts, online courses…

———————————————————————————
► Links of 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 via 510k: https://podcast.easymedicaldevice.com/58/

——————————————————————————–
► Social media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

——————————————————————————-
#medicaldevices #simplemedicaldevice #regulationcompliance

Please feel free to share this video with your friends and family if you found it useful.