Applying ISO14971 and IEC62304 - A guide to practical Risk Management 2017

  • Check with publisher
  • Published date: January 10, 2017
    • San Diego, CA, United States

Overview:
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.


Location: San Diego, CA Date: March 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Four Points by Sheraton San Diego Downtown
Address: 1617 1st Avenue - San Diego, California, 92101 - United States

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

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