SPEAKERS AND TOPICS
Topics Covered
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- FDA expectations for Multiple Function Device Products.
- Regulatory scope — distinguishing medical device functions from “other functions.”
- Safety & effectiveness assessment of other functions within multifunction products.
- Regulatory and documentation requirements for multifunction devices.
- ISO 14971-aligned risk management and risk assessment approaches.
- Cybersecurity considerations for connected medical technologies.
- Software, cloud, interoperability, and third-party risks in multifunction products.
- Real-world healthcare examples and lessons learned for practical compliance.
Ashwin Masurkar
Software Quality Engineer
Supriya Jamkhandi
Technical Manager, Software 2
Ashwin Masurkar
Supriya Jamkhandi
Topics Covered
- FDA expectations for Multiple Function Device Products.
- Regulatory scope — distinguishing medical device functions from “other functions.”
- Safety & effectiveness assessment of other functions within multifunction products.
- Regulatory and documentation requirements for multifunction devices.
- ISO 14971-aligned risk management and risk assessment approaches.
- Cybersecurity considerations for connected medical technologies.
- Software, cloud, interoperability, and third-party risks in multifunction products.
- Real-world healthcare examples and lessons learned for practical compliance.
Ashwin Masurkar
Supriya Jamkhandi
Topics Covered
- FDA expectations for Multiple Function Device Products.
- Regulatory scope — distinguishing medical device functions from “other functions.”
- Safety & effectiveness assessment of other functions within multifunction products.
- Regulatory and documentation requirements for multifunction devices.
- ISO 14971-aligned risk management and risk assessment approaches.
- Cybersecurity considerations for connected medical technologies.
- Software, cloud, interoperability, and third-party risks in multifunction products.
- Real-world healthcare examples and lessons learned for practical compliance.
GALLERY
Preview of the Seminar conducted by IZiel along with their partners.
This Webinar is conducted by IZiel
