Is Your Device a Secret Safety Risk? - Webinar CD/Transcript

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Is Your Device a Secret Safety Risk?: New Standards Spur FDA to Take a Closer Look

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 you unravel the complexities of IEC 62304, FDAnews presents a 90-minute presentation that will clarify who the rule affects, what it requires, and what you need to do to ensure FDA approval of your products.

At the heart of the requirement is patient safety – whether or not software impacts on what is called the Essential Performance (EP) of your 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 hoist 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.

Order NOW and you will find out how to secure FDA approval of your device by clearly demonstrating that your product safety testing is adequate. Specifically, you 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 your 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 you'll fully understand this complex requirement and what you must do to comply. And you'll get best practice tips to help you more easily implement what you learn.

This presentation is a must 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. Order Now for this critically important session.

  • 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

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.