Course Description:
In order to design safe and efficacious medical devices, many detailed design decisions will have to be made, documented and verified. The single most effective method to achieve a high level of safety and decrease the verification and testing effort is the correct decomposition and architecture of any system. Effective architectures not only allow achieving safe devices but also minimize the lifecycle cost of the device by reducing regression testing after changes. Smart allocation of user interface functions and separation of safety functionality will allow the use of graphical user interfaces without compromising safety or complexity.
This medical device design course will help attendees gain a basic understanding of failure types, failure modes and failure rates. Based on the failure behavior, different architectural approaches like redundancy, diversity and supervisory architectures will be discussed. Special emphasis is placed on risk and risk control allocation into architectural structures and the effect on overall design and lifecycle cost will be discussed.
This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design.
Learning Objectives:
Upon completing this course on medical device safety design, participants will:
- Understand failure rates, modes and types
- Know methods to address different failure types
- Be able to design basic architectures to address failure (single channel, multi-channel, hot-standby, control-monitoring)
- Address user interface challenges in architecture
- Understand risk analysis and FMECA (and why these methods are different) and their impact on safety
Seminar Fee Includes:
Who will benefit:
This course is designed for system engineers, project managers and R&D personnel tasked with developing cost effective yet safe medical devices. The following personnel will find this session valuable:
- Senior quality managers
- Compliance professionals
- Project Managers
- System architects
- Software engineers
- Design engineers
- Quality engineers
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 4:30 PM) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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Markus Weber Principal Consultant, System Safety, Inc. Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, he has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. He has helped multiple companies, from startups to Fortune 500 firms. |
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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