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Complimentary Webinar

October 27, 2021 | 1:00 p.m. - 2:00 p.m. ET

Watch Out for Wearables:

Medical Devices Regulatory Requirements & Concerns

Wearable medical devices market growth is attributed to a growing need for cost-effective diagnosis and treatments. The convenience and real-time data that wearable devices provide (i.e., fitness trackers, ECG monitors, blood pressure monitors, wearable biosensors, smart glasses, hearables, etc.) allows many medical industry, insurers, providers, and technology companies to incorporate them into their processes. These advances can offer remote healthcare that is safer, timelier and more convenient as it removes the need for the patient to be continuously transferred to the medical center.

But anytime a medical device has software and relies on a wireless or wired connection, vigilance is required. The software behind these products, like all technologies, can become vulnerable to cyber threats, especially if the device is older and was not built with cybersecurity in mind. As the wearable medical device market continues to grow to improve the lifestyle of patients and consumers, it brings quality and regulatory concerns. Although missing and incorrect data are widely known data quality challenges for wearable devices, regulatory concerns are also increasing about data privacy/protection and cybersecurity.

The presentation will outline:

  • History of Wearable Devices
  • Recent development for wearable devices
  • eHealth and mHealth devices
  • Definitions
  • Regulatory requirements, concerns, and recommendations
  • Forecast for growth
  • Conclusion


Bob Mehta
Principal Consultant
GMP ISO Expert Services

Bob Mehta is the Principal Consultant at GMP ISO Expert Services (www.gmpisoexpert.com) and provides consulting services in Pharmaceutical, Biotechnology, Medical Device, Active Pharmaceutical Ingredient, and Food/Dietary Supplement industries.  Bob has over 28 years of experience, including as a Principal Consultant in the Quality Systems, Training, ISO 9001, ISO 13485, and Regulatory Compliance areas.  Bob is a Fellow of American Society for Quality (ASQ) elected in November 2014.  He has written educational articles in the areas of Quality and Compliance for the following publications: Medical Device & Manufacturing (MD&M), Pharmaceutical Technology, Quality Progress, and Nutraceutical World.  He is an adjunct professor at California State University Dominguez Hills and California Polytechnic Pomona and teaches courses on Risk Management, Total Quality Management, Six Sigma Blackbelt, and FDA's Quality System Regulations.  Bob has co-authored a book titled “Process Validation” and the book was published by ASQ Press in July 2016. Bob authored the book “Implementing and Auditing ISO/IEC 17025:2017 A Practical Guide” which was published by ASQ Press in March 2019 and co-authored the book “Practical Process Validation which was published by ASQ Press in 2016.  Bob is the recipient of the 2017 Simon Collier Quality Award given by the ASQ Los Angeles Section.

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