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Another good session. Thanks Charles!

Iron

No, have never submitted a first-of-a-kind device to FDA.

Iron

Catching up on some of the archived courses.

Iron

Hello from Beaverton, Oregon.

Iron

hello all from Edmonton, Alberta

Iron

another great presention, well informative that enlighten our thoughts in terms of medical electronics..

i am now about to end, once again, thanks alot for a GREAT presentation by sir charles...

on slide 18 now...

i am now on slide 6 moving to slide 7...

now, i am about to begin the lesson with sir charles...

i am now about to download the educational material in line with the presentation to wrap up...

good morning to all of you and our dearly lecturer, sir charles...

another lesson for day 2 coverage...thanks once again...

Medical display Class II dev

Have a great day all!! See you tomorrow!

Iron

Hi Joe - saw you log in - GREAT!

 

Iron

Thanks Charles, I successfully logged on and attended the lecture, Joe in China!

Iron

@amansano - it can, depending on the circuitry and if you have an electrode that comes in contact with the patient or the operator.

 

Iron

Dear Charles, do you think for portable medical devices (powered by battery) 50/60Hz rejection would really be an issue?

Iron

Thanks again all!!! Great comments and questions!  See you tomorrow at 2PM EDT, 1800UTC!

 

Iron

@aminn - I'd like to address that on Thursday if I may, as we will talk about wireless communication then.  Short answer is that the interference and bands, etc are more FCC issues than FDA

Iron

Ditimar, we have had at least one 'simple' consumer device (exempt) that only required FCC p15 and no FDA requirements for EMC and ESD.  It didn't have any exposed metal or electrodes and was classified as fitness equipment (although it was used more in primary and secondary care centers than homes)

 

Iron

here it is again:

Can you talk about regulation regarding wireless communication say between a medical device and a smart phone, in the consumer setting and maybe hospital environment? Any special consideration regarding interference, frequency band, etc. 

Iron

I am sorry, but did anyone answer my question?

Iron

@cjlord, :) thank you very much

@ben, we ended up passing with Windows NT4.  I kid you not.

Iron

Covered a lot of ground. Thank you!

Iron

Did I miss a question?

Iron

Hi Charles, since there are no other questions... did you successfully pass 21 CFR Part 11 with Linux?

 

@cjlord ...

How differs (in general) EMC and ESD requirements between class I-III? My point is can one have exempt for simple and non-critical devices?

Iron

I do recommend that you read back through these comments - I am seeing some great and useful commentary from many of you - thanks!

Iron

Wow - lots of great comments, but only question I see (that wasn't answered by others - CMRR) is about the music on the audio channel.  That is one question that I can't answer!

Iron

What is the name of the musicial piece on the audio channel that is playing after the class today? Thank you.

Iron

Fine coverage of a lot of material in aaa compacted time frame in this lat 45 minutes.  Look forward to details tomorrow with Communications I.

[ TomHalEE ]

Iron

Better sign up for LinkedIn ... gotta get out more ... thanks Don H, Mike T

Thanks you  great info

 

Iron

Thank you Charles

 

Iron

Please send the next day's slide deck one day ahead of time

Thank you

Thanks Charles!

 

Iron

Thank you all!! I will be back in one minute and start answering questions!

 

Iron

The music is a little too much

Iron

Thank you Charles and Rich.

Iron

Another very good presentation.

Iron

Thanks Charles for great presentation.

Iron

Thank you Charles, Xie xie ni from Joe in China.

Iron

thank you Charles!

Iron

@Digital_Angel  There is a Digi-Key Continuing Education group on LinkedIn.

Iron

Thank you Charles for today's presentation

Iron

Thanks Charles.  Nice job.

Iron

Applause, Applause!

Iron

Very informative class... looking forward for tomorrow's session...

Iron

Thanks very much Charles & Rich; great class!

Iron

Thank you, Charles, for another great presentation!

Iron

Thank you. See you tomorrow.

Iron

@Dimitar, can your product be acceptable to the consumer based on an ESD / EMC failure ... not even talking about a medical device, what about a calculator or video game for instance ... most implementations are not too costly in resources

Thank you Charles.

Iron

Wow, thank you, great day!!

@Dig_Angel ... click on the timestamp above a post

Iron

Thank you Charles!

Iron

Thanks - a very interesting discussion and topic

Iron

Thank you Charles, another geart presentation.

Iron

Great class! Thanks Charles.

Iron

Hi, John. I just figured out who you are! Take care.

Iron

nice job CJLord ... 40 minutes seemed like just 20 ... point taken

FCC regulation, maybe?

Iron

Well, maybe you're around magnetic rocks for a system used in the field.

Gold

No, I just recognized who he is!

Iron

@john_m ... how does one send a note ... is there a Design News mailbox capability or blog area?

Can you talk about regulation regarding wireless communication say between a medical device and a smart phone, in the consumer setting and maybe hospital environment? Any special consideration regarding interference, frequency band, etc. 

Iron

Frank, I just sent you a note.   John

Iron

How differs (in general) EMC and ESD requirements between class I-III? My point is can one have exempt for simple and non-critical devices?

Iron

Thank you for the detailed explanatin, 78RPM

Iron

We had Gamma Camera, Gamma Counter needed a special classification.

Iron

frankziege, CMRR means that the same signal going to two input, e.g., noise, will ideally be rejected from the signal going into the amp.  The better this rejection, the higher the CMRR

Gold

Next question: Have any of you had a device that was a 'first of kind' that needed a special classification?

Blogger

CMRR is common mode rejection ratio

Gold

FMEA is fundamental to any product design

Iron

It is no way to avoid lawsuits if the device fails and harms the patient.

Iron

fear of lawsuits keep many potentially good products off the market

Iron

Risk Analysis is its own topic, methods such as Fault Tree Analysis or Failure Mode Effects (and criticality) Analysis are examples, and of course the entire design approach, practices, documentation are important as well ..

lawsuits are among the highest barriers form any business from expanding

Iron

second on the lawsuits "risk"... no matter how many risks you eliminate, someone will find a way to sue you (in US)...

Iron

storage safety considerations; battery acid leakage, and the likes

 

 

Iron

You need to verify the alarms do not always trip on any movement by the patient.  They get ignored.

Iron

Risk of Lawsuits!

Iron

Great to connect again with this great presentation.

Iron

Good afternoon from mexico

 

Question: There are sometimes exemptions for class I devices that allow a minimal amount of documentation and regulatory impact. Have any of you had an example where you were allowed an exemption on a device?

Blogger

had to upgrade adobe flash - nothing was happening

 

Iron

Finally got connected.

Description of hookup is too vague.

Jack in Boston

Good evening from Sweden

 

Iron

I should have just waited a few seconds for the answer :)

Iron

Who determines what class a device fits into?  Are there good guidelines for how to determine (e.g. - diagnostic vs. critical function)?

Iron

Hello, from M. Ahmed

Iron

Hello from Cal Poly SLO

 

Iron

Hello from State College, PA

Hello from Joe in China, good morning!

Iron

audio is good here on firefox

Iron

(I was just kidding about the baseball game.)  I'm here for electronics too.   :)   'Sides, todays game is a night game.  :)

Hello from Binghamton, NY

Iron

Now, audio is clear.

Iron

I had to close and reopen my browser a number of times yesterday when I was losing  audio.

Iron

@cjlord, I appreciate the breadth and depth of the topic.  Just making an observation.  In earlier tracks, there was a class on ISM Band, a Class on Zigbee, a Class on wireless networks in the factory and others (e.g. file systems) that helped pull all the various subject matter together.  I believe it is generally recognized that you are attempting to cover a lot here in just one course.  Simple observation, that I believe you affirmed is that it would probably take two more courses to likewise cover the "Medical Electronics" topic in fair detail .... press on ...

Hello from Sacramento.

Iron

Audio is loud and clear...

Iron

Hello from Greensboro, NC

Iron

My addio doesn't work properly.

Iron

good afternoon, everyone

Iron

Hello from Toronto, ON

Iron

You mean this isn't the live feed for the St. Louis Cardinals / Chicage Cubs baseball game?   :)    (Go Redbirds!!)

Hello from partly Sunny Atlanta.

 

Iron

Hello from sunny Mazatlan Mexico.

 

Iron

David Culp: At the top of the hour, the audio bar should appear on your screen.

Blogger

Greetings all.  Logged in from Buffalo, NY, USA.  Awaiting start . .  .

 

Iron

hello from Montreal

 

Hi to all,from Egypt

Iron

Hi from Rochester, NY

Iron

Hi all. Here from Reeves County Hospital in Pecos, TX.

Iron

Hello from Germany

Iron

Greetings from Wheaton IL

hello from Guayaquil, Ecuador

Iron

Good day from Anderson, SC

Iron

Digital Angel - want to team up for my live face-to-face classes?
Seriously, we are having to simplify a LOT for this broad-audience and very short series...

Iron

Please notify us with a posting when the Audio is available. Yesterday many seemed to have an issue with it. Thanks

Iron

Hello from Montana

Gold

Good day all from sunny Asheville, NC!! - I look forward to talking to you again today - we will start in about 12 minutes!

Iron

Finally warming up in NJ. I see someone from Colonia. Welcome. I'm about 40 miles north of you.

Blogger

Good morning to all from CA

Iron

Greetings from warm The Hague, NL

Iron

Folks, class starts in about 20 minutes. Download the presentation from the link above.

Blogger

Digital_Angel: thanks for enlightening me. Enjoy the class.

Blogger

Greetings from Colonia, NJ

Iron

i am here again from Ottawa, ON.

Iron

The sun is shining and it is not raining today, in Huntsville, AL.  We have had nearly 6" of rain in the last 3 days.

Iron

Good morning from rainy California!

Iron

Hello from Chantilly VA!

Iron

@richnass ... some of these topics listed are alluded to very generally in today's presentation ... Slide 18 of today's presentation does give a link to the FDA Regulation Guidance which can be helpful-

LINK -->> http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/, and as Charles mentioned yesterday, this could be the subject of an entire class related to 'Introduction to Medical Electronics'  ... 

TomBee posted a video that is also from the FDA that relates to this sort of general overview, that then requires training in each area depending on a Medical Device's classification as well as company policies ... A fair amount of material to cover for sure ...

Hello from Chihuahua, Mx.

Iron

Good day everybody!

Iron

first download slide.

 

Iron

Hi everyone, good morning.

Iron

Hello from Toronto.

Iron

I recommend some great overview online videos at FDA about the regulatory and Quality System regulations.

Checkout

http://fda.yorkcast.com/webcast/Viewer/?peid=dd2d4823b14a4e4ca6d60eae43c5ac9c

Iron

Hello from El Paso TX

Iron

Hello from Chicago

Iron

@richnass ... Yes, the Quality System Regulations, specifies 'Personnel Training' under it's requirement for "Design Controls".  As to Voltaire, Holmes and Illich - it is one perspective on the Medical Industrial Complex throughout history ... I could I suppose have quoted Socrates or Jesus (Physician, Heal thyself) or perhaps Dr. Gregory House ("Hang up a shingle and condemn the narrowness and greed of Western medicine, you'd make a damn fine living." [Episode #120 "Love Hurts"])... left those for another time ...

Good Morning from Sunny Boston; A 10 today!

Iron

Digital_Angel: Do your posts refer to this class? I'm not getting the connection. Please enlighten me. Thanks.

Blogger

Good morning from Chicago.

Iron

Modern medicine is a negation of health. It isn't organised to serve human health, but only itself, as an institution. It makes more people sick than it heals.  Ivan Illich, in Medical Nemesis (1976)

 

Doctors are men who prescribe medicines of which they know little, to cure diseases of which they know less, in human beings of whom they know nothing.  Voltaire (1694-1778).

 

I firmly believe that if the whole materia medica could be sunk to the bottom of the sea, it would be all the better for mankind and all the worse for the fishes.  Oliver Wendell Holmes, Sr., Lecture before the Harvard Medical School.

Good Morning from Tennessee

Iron

Good morning from Edmonton, AB

Iron

PERSONNEL TRAINING

Personnel training in 820.25 is one of the quality system requirements, which applies to employees that perform any activity covered by the QS regulation including all design activities.

 

Most technical employees need various degrees of training, as appropriate, in the medical device regulations, safety, labeling, human factors, verification, validation, design review techniques, etc.

DESIGN CONTROLS (continued)

DESIGN REVIEW
     Combination Devices
     Preparation For Reviews
     Why Design Reviews
     Types Of Design Review Meetings
     Design Review Requirements
     End Of Initial Design
DESIGN OUTPUT
     Documenting Design Output
     Acceptance Criteria
     Design Output Approval
DESIGN VERIFICATION AND VALIDATION
     Design Evaluation versus Specifications
     Software Validation
     Labeling Verification
DESIGN TRANSFER
DESIGN CHANGES
DESIGN HISTORY FILE

DESIGN CONTROLS

INTRODUCTION
     Coverage
QUALITY SYSTEM
     Personnel Training
DESIGN AND DEVELOPMENT PLANNING
     Interface
     Structure of Plans
DESIGN INPUT
     Input Checklists

The Safe Medical Devices Act of 1990 added design validation requirements to the GMP requirements in section 520(f) of The Act. Section 820.30 of the Quality System (QS) regulation lists the DESIGN CONTROL REQUIREMENTS that manufacturers should satisfy to be in compliance.

Good morning from Mobile, AL

Good morning from Scottsdale, AZ

Iron

Slides are here now

Iron

Good morning from Portland Oregon

Iron

@wonohkim: we are early. I am guessing the slides will be avialbe later

Iron

Good Morning from GA

Iron

Hi from OR, Looking For Slides...



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