market access market access JULY/08/AUG
market access market access JULY/08/AUG
market access market access JULY/08/AUG
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<strong>market</strong> <strong>access</strong><br />
Functional Safety Seminar<br />
hardware / software Design according to iec 615<strong>08</strong> (continued)<br />
Application of safety-related Bus Systems<br />
• Application of standards IEC 615<strong>08</strong>, En 954,<br />
ISO13849-1 and En 50159 to the described methods<br />
and measures for bus systems.<br />
• Basic requirements for the application of bus-systems<br />
• Deterministic approach<br />
- Transmission error, random hardware failure,<br />
systematic failure<br />
Topic Overview<br />
agenda<br />
1st Day<br />
1. Introduction, overview of the TüV Functional<br />
Safety Program Day One<br />
2. Introduction into safety Introduction<br />
engineering<br />
3. Application The of the medical international device standard <strong>market</strong> landscape IEC 615<strong>08</strong><br />
Part 1: General requirements and management of<br />
PAL<br />
functional safety<br />
The Japanese Pharmaceutical Affairs Law<br />
JulY/<strong>08</strong>/aug<br />
- Considerations of probability of transmission<br />
faults<br />
- Reliability of data transmission<br />
- Bit-failure rate<br />
- Failure-rate and failure-detection<br />
• Various Bus-Architectures<br />
• Examples for various bus-systems and safety<br />
considerations<br />
4th Day<br />
Summary of training - Questions and answers<br />
Speakers<br />
exam<br />
Duration approx. 3.5 – 4 hours<br />
Start: 11 am | End: approx. 3 pm<br />
Tamas<br />
Borsai<br />
the seminar will be held:<br />
2nd Day<br />
What PAL Means to You<br />
September 22-25, 20<strong>08</strong> (4 days)<br />
1. Examples concerning management of functional Start: 9 am | End: approx. 4.30 pm<br />
Lunch<br />
safety<br />
Courtyard Boston natick<br />
2. Application Gaining <strong>access</strong> of the international to Turkey/Ukraine/Russia/India/ROW<br />
standard IEC 615<strong>08</strong><br />
Title Here<br />
Loren impsom<br />
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Part 2: Requirements of E/E/PES<br />
3. Determination and<br />
EU<br />
evaluation<br />
Regulatory<br />
of<br />
Update<br />
safety-related<br />
parameter (practical examples)<br />
MDD<br />
342 Speen Street mp gobi pgiu a dpfio uhdpf obd pf k<br />
natick, Massachusetts 01760 dfp bj, dfgiab mpg obip.pgobi pgiu a<br />
dpfio uhdpf .<br />
Phone: 1-5<strong>08</strong>-655-6100<br />
Break<br />
3rd Day<br />
1. Determination and evaluation FDA Update of safety-related<br />
Fax: 1-5<strong>08</strong>-655-6104<br />
cost:<br />
Michael<br />
Brousseau<br />
Title Here<br />
parameter (practical examples)<br />
2. Application of the international DAY standard 2 IEC 615<strong>08</strong><br />
Part 3: Software requirements Introduction<br />
3. Practical example concerning part 3<br />
4. Requirements of Current tools State for configuration of IEC601 and<br />
parameterization of safety systems<br />
5. Requirements IEC of safety-related 60601 (2005) bus 3rdsystems Editionacc.<br />
$ 3,800.00 - Includes exam, training proceedings, Loren lunch impsom<br />
and refreshments<br />
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$ 3,400.00 - Without exam<br />
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To register, please visit: gobi pgiu a dpfio uhdpf obd pf k dfp<br />
www.us.tuv.com or call bj, dfgiab mpg obip.pgobi pgiu.<br />
1-tUv-rheinlanD<br />
The to sweeping IEC 615<strong>08</strong>. new approach to medical regulatory compliance (1-888-743-4652)<br />
Lunch<br />
Richard<br />
Morroney<br />
Special guest<br />
IEC 60601 (2005) 3rd Edition<br />
from Clinivation<br />
Loren impsom<br />
1
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