MedTech and Life Sciences commercialization expert, John Giantsidis of CyberActa, assesses the current regulatory environment around Medical Devices, the Internet of Medical Things (IoMT), and wearables. John shares best practices on how to gain regulatory approval and how to make compliance part of your company’s culture. Plus, he provides actionable advice on how to generate evidence and provide your prospects with quantifiable proof of value.
If you’re developing a new medical device, IoMT, or wearable solution, then this episode is for you.
John Giantsidis is the President of CyberActa, a boutique consultancy empowering medical device, digital health, and pharmaceutical companies in their regulatory, cybersecurity, privacy, data integrity, and commercialization endeavors. With deep regulatory, technology, quality, legal background, a broad range of experience over a 27-year career, and a sharp focus on tackling emerging risks, John can provide his clients with strategic yet pragmatic perspectives on addressing critical risks in a business-focused and impactful manner.
John advises clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA, MHRA, EMA, PMDA, and TGA premarket review processes, to post-market compliance, GxP practices, software validation, and Quality System requirements. Whether traditional medicinal products and devices, rapidly evolving medical and health technology products, such as a SaMD or digital diagnostic tools, he has extensive knowledge of the governing laws and regulations and broad-based practical experience with their application in advising clients to achieve competitive advantage by guiding on significant events that could adversely affect product quality, submission approval, compliance status, or pose a significant business risk. John is the Vice Chair of the Florida Bar’s Committee on Technology and a Cyber Aux with the U.S. Marine Corps. He holds a Bachelor of Science degree from Clark University, a Juris Doctor from the University of New Hampshire School of Law, and a Master of Engineering in Cybersecurity Policy and Compliance from The George Washington University. He frequently writes and speaks on a broad range of current issues facing the MedTech and life sciences industries such as building privacy and cybersecurity in medical devices, the evolving regulatory landscape in this rapid pace of technology-driven change, and addressing the challenges of product development, testing, generation of evidence, proof of value, implementation and adoption of novel medical and health technologies.
A privately owned boutique consultancy specializing in technology, security, and privacy within the digital health industry.
CyberActa provides services spanning the product life cycle, from product development and clinical trials to post-market compliance. We have extensive knowledge in developing solutions that meet the needs of patients, healthcare providers, and regulators.
- Website — www.cyberacta.com
- twitter — @cyberacta_com
- Linkedin – https://www.linkedin.com/company/cyberacta
The Summit on Embedding Privacy in Digital Health
Digital health companies are compelled to adapt to an increasing number of privacy regulations imposed by governments to protect consumers. This first-of-its-kind Summit provides digital health companies detailed and practical information on current regulatory requirements and on how to incorporate privacy by design into their development and commercialization efforts.
- Episode 171: Office Hours: Does My Software Need FDA Clearance (SAMD)?
- Episode 180: Building the First FDA Approved Autonomous AI in Healthcare – Dr. Michael Abramoff and Seth Rainford
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Music by StudioEtar