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Jul 14, 2022
  • Digital Live Event

UL Solutions Medical Compliance Day

Through this series of virtual modules, we will explore the latest on safety, EMC wireless, cybersecurity, and interoperability. We will also distinguish between “wellness” and “medical" devices.

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Date & Time

Starts

Jul 14, 2022 10:00am CDT

Ends

2:50pm CDT

Please feel free to attend any part of the event.

Agenda

10:00AM - 10:40AM Things to know about IEC 60601-1 amendment 2   
10:40AM - 11:20AM Electromagnetic compatibility (EMC) for medical equipment and in vitro diagnostic (IVD) equipment    
11:20AM - 12:00PM Wireless module compliance for medical devices: what you need to know    

12:00PM - 12:40PM Break

12:40PM - 1:20PM Wellness device or medical device?    
1:20PM - 2:00PM   Medical device cybersecurity     
2:00PM - 2:40PM Your medical device is smart, but can it connect?     
2:40PM - 2:50PM  Wrap up

Things to know about IEC 60601-1 amendment 2

The IEC published amendment 2 to 60601-1 in August 2020. With updates to the base standard published, the amendments to the collateral standards quickly followed.

While many of the updates to the base standard consist of corrections or clarifications to existing requirements, some of the updates require effort on the part of manufacturers to upgrade from the previous version. This includes updates to:

  • Risk management standard ISO 14971:2019
  • Usability standard IEC 62366-1:2015 + AMD 1:2020  
  • Software standard IEC 62304:2006 + AMD1: 2015    

Clause 8 updates allow IEC 62368-1:2018 compliant devices to provide means of operator protection.   
We will share details of the changes, possible areas of concern and which collaterals have undergone major changes. We will also share key points to consider when using 62368-1 devices in your design such as a means of patient protection.

Electromagnetic compatibility (EMC) for medical equipment and in vitro diagnostic (IVD) equipment

  • We will provide an overview of the recent changes to the medical EMC standard IEC 60601-1-2 and the IVD EMC standard IEC 61326-2-6. These changes not only impact testing but can also impact manufacturers’ responsibilities regarding these devices.  
  • We will explore the applicability of the standards, changes, and what information you need to provide to the EMC laboratory to support testing.  
  • We will provide details on how the U.S. Food and Drug Administration (FDA) recognizes these standards for both medical and IVD devices.

Wireless module compliance for medical devices: what you need to know

UL Solutions’ wireless compliance experts provide a high-level overview of U.S. and EU radio approvals and how using certified radio modules can help to streamline regulatory approvals.

This module will review:

  • U.S. Federal Communications Commission (FCC) modular requirements, including whether you need to recertify a host product if the radio frequency (RF) module has FCC approval, and what you can do if you cannot meet the RF module conditions
  • Information on the EU Radio Equipment Directive requirements you need to meet at the system level when utilizing an RF module with CE Marking
  • A look at key countries in Latin America, Asia and Europe, whose requirements may allow the leveraging of a modular approach
  • A short list of essential module features to keep the radio regulatory approval overheads to a minimum for medical devices

Wellness device or medical device?

In this module, we will discuss the difference between a medical device and a wellness device. We will explain the importance of the manufacturer’s claims about the product and how this can impact the classification.

Also included in the discussion:

  • Testing assurance using standards
    • Medical equipment 60601 series of standards
    • Health and hygiene wearables
    • Information technology wearables
    • Certification
  • Biocompatibility/toxicity
  • Human factors/usability
  • Testing assurance to support claims
    • Accuracy of measurement, number of steps, distance, laps
    • Environmental claims
    • Durability
    • Custom

Medical device cybersecurity

Many people think of HIPAA, GDPR and data privacy laws when they consider protecting healthcare data. However, as the healthcare ecosystem becomes increasingly interconnected and reliant on computing and communication technologies, it has become increasingly important to understand why and how these systems are facing attacks, what kinds of data require privacy and what kinds of data can lead to potential patient safety concerns.

We will explore the FDA-recognized requirements for medical cybersecurity and how implementing these requirements can help improve your device’s and your organization’s cybersecurity posture as you participate in the smart health ecosystem.

Your medical device is smart, but can it connect?

Our specialized team at UL Solutions comprises experts on Wi-Fi, Bluetooth®, smart homes and mobile phone apps. We perform interoperability and quality testing with smart connected devices. The smartphone has ushered in revolutionary capabilities, providing opportunities for manufacturers to develop powerful application offerings for industry and consumers. With this power comes the challenge of compatibility across a wide variety of mobile phones and mobile phone OSs, chipsets and Wi-Fi router technology. We will cover the benefits of interoperability and application quality testing.

Speakers

Pam Gwynn
Bob Delisi
Mark Briggs
Paul Hilgeman
Anura Fernando
Martin Hochman
Mike Ferrer
James Stoia

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