Webinar

Connected Devices and Quality Management: Meeting Regulatory Demands Under cGMP and EUMDR

Does your Quality Management System have the right capabilities to ensure that your XBU Connect Device will be safe and effective?

Placing a connected device in the marketplace presents new risks for your quality management system (QMS). The QMS processes impacted include but not limited to: Regulatory, Clinical, Design Control, Risk Management, Validations (design, process and software), Post Market Surveillance. This presentation will look at the present cGMP and EUMDR regulations and their impact on connected devices.

This is the first presentation from day 2 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy.

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    Presenters

    Richard (Rick) Rios

    Medical Device - Quality and Regulatory Consultant

    With over 25 years of experience in systems analysis and quality management, Rick has delivered high-ROI solutions across a range of leading industries. He has successfully developed, integrated, implemented, and audited quality systems in accordance with standards and regulations such as ISO 13485, 21 CFR 820, MDSAP, EU MDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540, and the Baldrige Performance Excellence Program. He has also served as a New Mexico Quality Award Examiner.