3hr Virtual Seminar on Designing Medical Device Software to Prevent Product Recalls

Instructor: Dev Raheja
Product ID: 701954
  • Duration: 180 Min

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

Why Should You Attend:

Many medical devices are controlled by software that governs key aspects of the user interface, and performs key safety functions. Users often do not realize the extent to which software determines many of the key functional and performance characteristics of the system until something goes wrong. Unfortunately, in some cases, the software does “go wrong” and compromises performance reliability and patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. The occurrence of a software error should be a highly unusual event.

The trend of recalls of products containing software is up. Historically, software safety has been focused on the software development process and system-level testing.. Having skilled engineers and a rigorous software development process, as required by the FDA is important to help to minimize errors. However, assessing the software development process provides only a partial reliability of the software, and system-level testing that would comprehensively test the software is currently beyond the state of the art except for a very simple system. How we design the software reliability and safety is critical in preventing recalls.

Attend this training to learn proven techniques for designing reliable and safe medical device software that can prevent product recalls.

Areas Covered in the Seminar:

  • FDA Quality System Requirements.
  • Principles of software reliability.
  • Principles of software safety.
  • Software requirements analysis methods.
  • Software Failure Mode and Effects Analysis.
  • Software Hazard Analysis.
  • Software structure for reliability and safety.
  • Software architecture for reliability and safety.
  • Manual code reviews.
  • Software verification.
  • Software validation.
  • Exhaustive system testing.
  • Risk analysis.

Who Will Benefit:

This webinar will provide valuable assistance to all Medical Device companies/ manufacturing sites. Those that would benefit most would be:

  • Software R&D
  • Software Engineers, System Engineers
  • Software Project Managers
  • Hardware Development
  • Product Management, Product development
  • Safety
  • Regulatory
  • Purchasing & Production
  • Quality Assurance Managers
  • Suppliers and Software Vendors

Personnel in the hospital and healthcare industry would also benefit from this training.

Instructor Profile:

A respected and sought out expert on medical device and hospital care safety, author Dev Raheja draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety and reliability. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. He applies analytical tools that can effectively measure efficiency, establish evidence between Lean strategies and patient satisfaction.

His focus is on using various types of innovations to encourage a culture conducive to high return on investment. He is the author of the books Assurance Technologies principles and Practices, and Safer Hospital Care. He has served as Associate Professor for the PhD degree in Reliability Engineering at University of Maryland during 1994-99.

Follow us :
Latin America: Regulatory Compliance Requirements for Life Science Products
Risk Management in Medical Devices Industry

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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