FDAnews Announces — Is Your Device a Secret Safety Risk?: New Standards Spur FDA to Take a Closer Look Webinar, Feb. 26, 2015

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Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware. To help devicemakers unravel the complexities of IEC 62304, FDAnews will present a 90-minute webinar on Feb. 26, 2015 clarifying who the rule affects, what it requires, and what companies need to do to ensure FDA approval of their products.

Is Your Device a Secret Safety Risk?:
New Standards Spur FDA to Take a Closer Look
**FDAnews Webinar**
Feb. 26, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DeviceSecretSafetyRisk

Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware.

But many device companies remain unaware that the devices they manufacture must meet this standard.

That may be because there's confusion stemming from a key guidance, in which the requirement is called both voluntary and mandatory.

To help devicemakers unravel the complexities of IEC 62304, FDAnews will present a 90-minute webinar on Feb. 26, 2015 that will clarify who the rule affects, what it requires, and what companies need to do to ensure FDA approval of their products.

At the heart of the requirement is patient safety — whether or not software impacts on what is called the Essential Performance (EP) of the device — thus putting a patient at risk in the case of a software failure.

This level of risk can be hard to discern at the manufacturing level. For example, what would happen if a host manufacturer didn’t properly vet the software that signaled it to lower the patient at a certain speed? Lowering a patient too quickly (or not all) can quickly turn into a risk management nightmare, with IEC 62304 regulatory and legal implications.

Register now and find out how to secure FDA approval of devices by clearly demonstrating that product safety testing is adequate. Specifically, attendees will learn:

  • How to identify the two biggest pitfalls: documentation and software pedigree.
  • How to understand and address 3 significant non-compliance factors: software partitioning, document development, and version control/updates.
  • How to correctly prepare a device for approval and marketing with a detailed action list.
  • How to write a Test Report Form that will stand up to FDA inspector scrutiny by demonstrating clear compliance or a defensible explanation of why the device is exempt.
  • How to assess the 3 keys of successful compliance: defining operational and manufacturing processes, documenting and assessing operational risks, and defining controls.
  • And more.

Practical examples will be presented to ensure that devicemakers fully understand this complex requirement and what they must do to comply. And manufacturers get best practice tips to them more easily implement what they learn.

This is a must-attend event for devicemakers. Software design failure is the #1 problem leading to FDA device software recalls, which are on the rise, doubling from 2002 to 2012.

IEC 62304 was implemented to fix this problem. Take an important step in understanding and complying with it. Register now for this critically important session.

Meet the Presenter:
Rita King, CEO of MethodSense, has served as a regulator, technologist and professional auditor for more than 23 years, garnering a well-deserved international reputation as a regulatory expert. She has been a participant in numerous national and international committees to develop industry standards and regulations.

Rita is a founding member of the Underwriters Laboratories team that defined, launched, and managed the operations of the first US program to evaluate safety critical software used in commercial and medical devices. She also contributed to the development of the ANSI (American National Standard Institute) approved Standard for Safety Critical Software, UL 1998.

Who Will Benefit:

  • Compliance/regulatory affairs professionals
  • Managers of GMP facilities
  • Supply chain managers
  • QC and analytical methods scientists and managers
  • QA directors, managers and personnel
  • Regulatory attorneys

Conference Details:
Is Your Device a Secret Safety Risk?:
New Standards Spur FDA to Take a Closer Look
**FDAnews Webinar**
Feb. 26, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DeviceSecretSafetyRisk

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/DeviceSecretSafetyRisk
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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