Risk Management/Risk Analysis for Medical Devices

Course 0716 - 2 Days - 1.4 CEUs

$995 USD
$895 USD with 30-Day Prepay Savings
$497 USD for Third Attendee
$447 USD for Third Attendee with 30-Day Prepay Savings
Save 10% to 30% in our Customer Rewards Program


Key Session Topics

• Understand the expectations of FDA and the EU in applying risk analysis to medical devices
• Understand the application of the ISO 14971 standard to medical devices
• Understand the application of risk analysis methodologies such as FMEA and FTA to medical devices
• Understand the principles of risk management planning in developing procedures and practices to analyze, evaluate and control risks
• Learn how to use a product safety audit to identify potential areas of risk exposure and liability exposure

Dates, Locations, and Registration  

How to Register

You can register for a course in either of two easy ways:

• Call us at (800)374-3818.
• Click on a date in the table below and complete the online registration form.

Register online or call 800-374-3818.

6/17/2008 - 6/18/2008 Indianapolis, IN Knowledge Services

7/16/2008 - 7/17/2008 Wellesley, MA The Center for Executive Education at Babson College

11/6/2008 - 11/7/2008 Orlando, FL MicroTek Orlando

12/9/2008 - 12/10/2008 San Diego, CA Sofia Hotel

If you have questions about this course, submit a Course Information Request or call us at 1-800-374-3818. To learn about the savings and instructional benefits of training five or more participants at your location, submit an On-Site Quote Request or call us at 1-800-374-3818. To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a Customer Rewards Request or call us at 1-800-374-3818.

Course Objectives
To provide understanding of risk management as well as risk analysis and how they apply to medical devices; to develop the skills necessary to apply risk management and risk analysis methodologies, such as FMEA, to medical devices throughout product life cycle.

Risk is a measurable factor. It is defined by safety specialists as a function of hazard severity and the probability that a hazard will occur. Safety, however, cannot be measured precisely. It requires a judgment by designers and production professionals acting together with management, taking account of what is technically and economically feasible. The assessment of safety involves balancing the risks that cannot be eliminated from the product against the benefit and utility of the product. These two factors (probability and severity) form the basis for a product safety profile, which provides management with information to decide whether to bring a device to market.

Risk management is required by ISO 13485:2003. Risk analysis is required by FDA’s Quality System Regulation (QSR) and the Annex I Essential Safety Requirements of the European Union’s three Medical Devices Directives (Active Implantable, Medical Devices and In Vitro Diagnostics). The EU requires a risk analysis for all medical device product family technical files, including those already on the market. The FDA initiated its risk analysis expectations on June 1, 1996 and requirement June 1, 1997. Risk management/risk analysis are not only required during design control, but throughout the entire product life cycle including all aspects of Product Realization. For sterile packaging, risk analysis is expected for design validation, process validation and distribution validation.

Course Outline
This 2-day course examines both risk analysis and risk management and is designed to give practical applications of these methodologies to their devices and device packaging (where relevant). For risk management, participants will review the application of the ISO 14971 standard for medical devices. Participants also will review the use of FMEA (Failure Mode and Effects Analysis) and FTA (Fault Tree Analysis) to conduct risk analysis to identify hazards, their severity and the probability they might occur.

Using case studies, hypothetical devices or actual company devices, and interactive discussions, participants will apply the principles of risk analysis to medical devices. Following the risk analysis, participants will apply risk management principles to their devices including regulatory requirements, technical costs, accident costs, liability costs and insurance costs, which affect decision making on the acceptability of risks in bringing a device to market.

Who Should Attend

• R&D Managers / Engineers
• RA / QA Managers / Engineers
• Product, Project and Program Managers
• Management Representatives
• Internal Auditors
• Multi-discipline Design Team Members
• Design Review Team Members
• Sales and Marketing Management

Prerequisites
There are no specific prerequisites for this course.


What's Included in the Price
The course price includes:

• breakfast, lunch, and refreshments each course day -- special dietary needs are no problem
• a student manual developed by experienced instructional designers
• a copy of the standard (where applicable)
• forms, templates, and worksheets for use back at the workplace (for auditing and other applicable courses)
• certificates upon completion of course requirements

Hotels:
Although hotel reservations and accommodations are not included in the course price, we do secure discounted room rates for most of our courses.

Training at Your Location:
Please contact us at 1-800-374-3818 for information about on-site pricing.


Support from Registration through Certificate of Completion
At every step of the public course process, the SAI Global Customer Relations team is singularly committed to providing an unparalleled level of support so you can focus on the learning event instead of on preparations and logistics.

1. Once you register for a course by phone, by fax, or online, we send you a registration confirmation e-mail.
2. Approximately 3 weeks prior to the course, or if you register closer to the start date, we mail and/or e-mail you precourse materials, if applicable.
3. If any changes to course/hotel location occur, we contact you immediately.
4. Approximately 2 weeks prior to the course start date, we e-mail you a course reminder to confirm your attendance.
5. For the course itself, we provide everything you need to facilitate your learning experience.
6. At the conclusion of the course, the instructor submits test scores (where applicable) and other necessary paperwork to the home office for processing.
7. You receive a certificate of completion and confirmation of continuing education units (CEUs) earned.