Seller's product certification requests?

[norty303]

I am SOOO glad I'm not living over there.

To state the f**kin' obvious, despite doing it with the best intentions, they've got themselves so caught up in the red tape and beaurocracy, its made it sort of pointless.

I feel for you guys and I hope they look at some sort of reform in the near future but it doesn't sound good.

[taggalucci]

I wasn't aware if the lifetime compliance management requirements. To me that's a tad excessive. That's like making a car manufacturer responsible for solely providing ongoing maintenance facilities for ever car in every location they're in use, never mind preventing your customer from ever removing the seatbelts! Surely a non-manufacturer related, though qualified service centre could perform the same maintenance and keep the projector certified?

If the hoops are too costly and difficult (within reason) to jump through then the CDRH/FDA are only contributing to the problem in my opinion. If you make compliance too hard to attain, then why bother making any of your projector compliant? I.e. If you're going to risk non compliance because you can't fulfill the lifetime QA, then why bother with an interlock? Not that I am recommending this.

As for parts obsolescence, surely the components don't have to be exactly the same (part numbers) but should simply fulfill the same capabilities, power ranges, wavelengths etc?

[X-Laser]

Well there is a slight distinction I would draw there which is that:

1) The manufacturer is not required to keep the product working for its entire life, it is required to keep it COMPLIANT for its entire life. So, if the laser dies after two weeks the product is still compliant because it is non-functinal. I personally think that that is a reasonable requirement. If someone chooses to recertify a product having been rebuilt at a later date, then they become the new manufacturer.

2) Part of the issue with any given projector is that we tell the FDA how it is built, and what tests we perform to ensure it is built properly. An service center would have to follow that same procedure, and keep records of the results of those tests, in order to keep the product compliant as originally made. Because there are no manufacturing or service standards in the industry as a whole, standardizing that process is almost impossible across manufacturers. Then, who determines who is "qualified?" Its a problem so people break the rules, everyone gets legal heartburn and more rules are made.

I hate to tell you guys but it is not just FDA. IEC is very similar in many respects. The primary difference is how and to what extent it is enforced in each jurisdiction. Our products are actually mostly certified under the harmonized IEC/FDA rules laid out in 60825-1.

[slicklasers]

Unfortunately SOME laser manufacturers are not really Manufacturers... they just try to take someone else’s box, put some lasers and scanners in it and call it legal... Well that is NOT the case. YOU MUST BE A MANUFACTURER ON RECORD... YOUR VARIANCE MUST STATE THAT YOU ARE ABLE TO MANUFACTURER LASER PROJECTORS, AND NOT JUST LASER SHOWS. If you are not a manufacturer on record, you are just the same as all this Chinese company’s trying to sell their lasers with certifications that do not exist.

I AM a CERTIFIED MANUFACTURER, and am getting tired of everyone thinking they can just slap together a projector and call it legal... Even if I were to sell you an enclosure, unless you are a Manufacturer, you cannot put lasers into it and call it legal. You wouldn't even believe the projectors I have seen that people are claiming are legal... even some built by respected fellow PL members that sell projectors, putting no case interlocks on class 4 lasers, no restart, and selling them to other board members.... NOT COOL!!!

And another thing, DO NOT TRY TO UPGRADE YOUR CLASS 3B laser to a CLASS 4!!!! It is then going to be ILLEGAL and you might as well have bought a cheap Chinese projector if you are going to be illegal.

It is time for all the US members of PL to take a stand, and FOLLOW THE RULES!!! If you are going to do a show, have a variance and send in the show notification. If you are going to build projectors, GET YOUR MANUFACTURING VARIANCE, spend the money and time that us LEGAL manufacturers have done, and make a product report, a user’s manual, put restart's on class 4 lasers, put housing interlocks on class 4 lasers.... GET A CLUE!!!!! QUIT SAYING IT IS A GREY AREA, it is clearly spelled out in blue, black, and white.... you can read it all here
http://www.fda.gov/MedicalDevices/De.../ucm094445.htm

[allthatwhichis]

I started this thread to get a discussion going and I appreciate that professional input but I have to state something. I just built a projector that incorporates all the safety features of a class IV projector (interlock circuit with redundant case intrusion sensors, manual reset button, safety shutter and key lock) and just sent in my product and show report as a manufacturer, after speaking with several laser safety specialist about my projector AND paperwork... It is NOT that hard. If I can do it... It can't be TOO HARD at all.

I think all the projectors being sold by overseas manufacturers and imported to the US should be done so legally, but I don't think anyone should be scared into thinking it is a lost cause to not only get your own projector compliant or getting overseas manufacturers from manufacturing compliant projectors.

[X-Laser]

Absolutely right. It is not that hard... if you are willing to put the time and money into making something that is compliant. I would bet that if the EU as a whole started actively enforcing IEC you would have a lot more people making the effort.

It is also much easier for US based laserists because we have the infrastructure here to be compliant more easily. I wish more people would be compliant... we would be happy to compete against people doing things the right way because then our stuff wouldn't seem so "expensive" relative to the uncertified fire hazards that are being snuck in as "stage lighting."

[slicklasers]

Absolutely right. It is not that hard... if you are willing to put the time and money into making something that is compliant. I would bet that if the EU as a whole started actively enforcing IEC you would have a lot more people making the effort.

It is also much easier for US based laserists because we have the infrastructure here to be compliant more easily. I wish more people would be compliant... we would be happy to compete against people doing things the right way because then our stuff wouldn't seem so "expensive" relative to the uncertified fire hazards that are being snuck in as "stage lighting."

Exactly.... +1 ......

[allthatwhichis]

What I don't see is what is so expsnsive about making a projector compliant; the parts to make my projector compliant couldn't have cost over $100 and it is a self certification process. It took me some time to build as I am definatly not the electronics whiz... yet. Once I get my varience it wouldn't take much to get my case reproduced at a machine shop and have the same lasers I have put it and sell it under the same varience. If I got the lasers at retail it might cost me $2500 tops with awesome optics, mounts and decent scanners; $3500 with CTs... Technically the red and blue lasers could be built in house for much less than retail. (go ahead everyone, laugh about the though of me building lasers...) I just don't see the extensive cost involved with making a projector compliant and getting it certified and I think that is what has a lot of people scared enough to not do it. A box is a box, and an interlock circuit is just a bunch of cheap solid state components installed in a certain configuration. Again, if I can do it...

The paperwork was kinda a pain in the ass to get together although I had a lot of help. Now it is just a waiting game. I would eb more concerned with people going out and doing show without liability insurance and such... which I am in the process of getting...

[dsli_jon]

...without liability insurance and such... which I am in the process of getting...

One quick name for you: Burlington Ins. Co. I can get you contacts, if you need, when I get back, next week...

Quick other note: +1 to the 'it's not that hard...' - AMEN. and +1 to slick Rick and Dan-X for your 'support' of this all...
I can't be the only 'loco gringo with a megaphone' around here...

peace
oh, and lol...
j

[X-Laser]

Yeah, I hear ya, but this is one of those things that is not that simple. For you, in your situation, I can totally understand your perspective. I don't mean to minimize hobbyists in any way, but it is much easier for you guys. You can make a simple circuit and throw it into a projector and it will work fine... maybe it will work fine forever. Maybe not... When something breaks, you fix it and at the end of the day that $10 circuit really doesn't cost much more than that.

For us, we design a simple circuit and then we have to get several hundred of them made. They have to withstand heat, cold, intense vibration, drops, spills, roadies and the back of some guy's van. A board that costs ten dollars is not bad, but when you have to get 250 of them to get a 10% price break... all of a sudden you have a lot of dead money. Then some guy does something stupid, accidentally discovers some flaw in the design which would never have shown up in the shop, and you now have to replace $2,500 worth of parts which are now trash. Now you are at $5K and a partial recall later and you have spent WAY more than the other guy.

Compliance is easy when you can take responsibility for the product from birth to death. Sending them out into the world where booze, disrespect and the indignities of performing get thrown into the mix is a totally different story when you have to ensure that the projector will 'remain compliant under any reasonably foreseeable scenario.' Get it wrong once and it will seem MUCH more daunting the next time.

The reality is, 40% is a fair markup for most of our units due to costs directly associated with compliance. Not profit, cost.... not counting any mistakes... not counting new ideas and concepts. Now take that and multiply that out over buying good quality diodes with the right paperwork, making and keeping current spec sheets, user manuals, product videos, a media rich website, answering questions from more than 200 dealers and contractors about compliance and safety issues, DVD's with setup videos, MAKING the setup videos. The best way to teach someone how to do something is to show them but do you have any idea how much making training videos costs. Our current user DVD cost us almost $20,000.00 to produce and we were being frugal about it. Users must be supplied with proper training materials. That is a compliance cost. There is a 50/50 chance that I can even read a manual coming out of Asia. You yourself don't even really have to write one.

For everyone else, even just taking the time to understand the rules is daunting much less filing out x dozens of pages of data about it. We had to submit more than 200 pages of data in our first product reports. That takes time to compile, money to be prepared, boatloads of money for testing to ensure that the data is accurate, more R&D time and money to do endurance and lifetime testing to make sure that xyz thing isn't going to fail when it gets humid. It cost us about 100 man hours, maybe $5,000 and a whole lot of frustration to get a box made which would provide optical alignments a better degree of safety in west coast shipments because we CAN'T allow people to open the housings on the other end to fix a misalignment. One gets bumped, or drop kicked by a disgruntled UPS worker, and we have to pay to ship it back to us, pay tech time to realign and recertify it and then ship it AGAIN back to the west coast while holding our breath because no shipping company pays damage claims for optical alignment. In the last three months, we have paid more than $2,000 in labor, shipping and materials to fix shipping misalignments.

The non-compliant guy sticks it in a box and pays 3% to a customs specialist who figures out how to sneak it through and then gets to forget about it.

I'm not ranting, that's just our life. And all of those costs have to be covered somewhere otherwise we are out of business.

Best of all, that whole system has to be devised, reported and approved BEFORE it can be tried. And then we spend time documenting where the failures were and how we corrected them and submit that for approval. I get why we have to do it, but the hidden costs are mile high for people trying to be on the right side of the law.

For a current example: We have a little secret project we are working on. Nothing earth shattering but a neat little project that has a unique compliance angle. We have spent six months, AT LEAST $10K in labor, materials and outside expertise and endless late nights in testing to be even able to show it to someone who may want to buy it. If they don't that money is dead. If they do, we will do well after the 500th unit finishes covering our setup costs. It is a huge gamble and even on a much, much smaller scale - doing it right can easily triple your build cost. Then you have to make a margin to live, then you have to have enough reasons for someone to pay 50% more for yours than a similarly specified European laser which is 'fully FDA compliant' but actually isn't and couldn't live up to the specs on its best day.

Then you have to put $50,000.00 in the bank for the day that those "europeans" decide to make an issue about you telling the truth... or some other guy trying to muscle you into paying him a royalty on his barely tangentially related but totally irrelevant patent... or some other guy who wants a UL certificate for a classification of product which doesn't exist... or to hire an attorney to file customs complaints because some Chinese company ripped off your name and are selling illegal lasers and then trying to make the warranty work your problem.

And there is oh so much more... as I said: not quite that simple, and it ALL comes back to compliance.

[drm916]

that def puts it into prospective. And this demonstrates how suprising it is that your able to offer your products at the competitive prices that you do.

Your prices are great and I hear that the lasers are very high quality. The only thing holding me back from purchasing is that I want analog drivers on the projector. Analog is the best way to go for the best color creation. So... please, please, please make an affordable analog RBG. Or have an affordable analog upgrade option.

[X-Laser]

Working on it brother. Literally, the first steps have already been taken and then we will embark on the three dimensional puzzle that will be getting it into the box. =) Ill let you know.

[drm916]

Working on it brother. Literally, the first steps have already been taken and then we will embark on the three dimensional puzzle that will be getting it into the box. =) Ill let you know.

I will want one or two or three! Ideally I will want 3 projectors. Selem gave me the laser bug pretty bad.

[drm916]

Working on it brother. Literally, the first steps have already been taken and then we will embark on the three dimensional puzzle that will be getting it into the box. =) Ill let you know.

Dan - Any updates? Still interested.

[X-Laser]

Yep, we got it all put together and are underwhelmed in part because it is too much stuff for the housing we chose and in part because some of the components are not playing nicely together. I've got you first in mind when we have something we are happy with.