The HTDS Process Through Certification

Last time we spoke about product certification UL, SEMI and CE for Semiconductor Manufacturing Equipment, which is a very specific niche and where our business started. However we have expanded way beyond that and let’s talk today more broadly about all types of equipment, everything from life sciences and medical equipment to oil and gas exploration equipment to clean energy, consumer products, and machine tools. Pretty much every other piece of equipment out there is going to fall into this conversation here today.

Let me walk you through our process, the HTDS process, that we take you through in order to have your product certified and get you to market practically, reliably, timely and on budget.

The first thing that we do is have an initial call and share some documentation so that we can get a sense of what equipment it is that you are building. This will immediately let us determine the hazards involved for your product. Most products today are going to have electrical hazards. Very few do not have electrical hazards and with that said we deal with mechanical hazards as well. From there you are going to have other hazards too, maybe hot surfaces or heated surfaces or thermal just from batteries or battery issues. Other possible hazards are present if there are sharp edges or rotating parts. Every little process will be evaluated. Each of those hazards in product classes will give us the scope that we need to proceed with.

Some companies like to have a non-disclosure agreement in place before they move forward with this initial conversation and that is perfectly fine. Some clients need this and others do not.

From this initial conversation, we will also know what countries your product is going into, what listings, standards, and certifications you will need. This allows us to rapidly quote the cost and timeline of the project. Steve and his team can do this so quickly because they have done so much of this work over the years. Now the exception to this is if you are on a large development project. Let say you are doing a R&D project and you are working your way through what kind of protection techniques that we need to use for something that is very different. For example, if you are doing a process that is one off or that the standards don’t deal with exactly, Steve and his team will let you know and we will work the project on time and materials. In general, we can give you a firm, fixed price of what, how and when to get certified. This is one of the reasons that we are so practical and easy to work with.

From there we will support the development and collaborate with you, either on the design or any design iterations, in order to make the product conform. This is great because in a lot of cases, you might find out from a third party or test lab that your product doesn’t conform and they leave you with the question of how do you get there. Or you might have stepped into this process too early and you are testing to the wrong standard or testing to a standard that is not necessarily wrong but if we were able to get you into a different standard you would be able to conform with the design the way it already is. We support all of this development and help you move it forward.

We develop a project plan and a test plan and then we can begin to execute with you and your teams.

We will do a deep review and look at all the details, critical components and your bill of materials. It is very useful when you are developing your product and bill of materials to keep track of all the cut sheets, data, and keep that sorted and available so that we can use all of this to do the evaluation. Once you are complete, we can put all of this into your technical construction file. We will collaborate on this process, as your team will do most of technical construction file and we’ll help design the structure and give you the outline of what needs to be there. Then our work will get loaded into the technical construction file and then your team will load all of their work into it.

Quick side note about the technical construction file, it just has to exist electronically in an archive somewhere. You will probably never need it, but it is always better to have it documented and on hand.

Once we get through this portion of the process, if you need to go out to a lab …Let’s say you have something that does require UL listing or it is a hazardous location device or has a particular medical use, anything that is going to have a particular need for a internationally or nationally recognized test lab, we manage that as well. We scope and quote this on a regular basis. This week we’ve got 4 going. We know how to work with the teams and in fact, many of them are friends, which helps you get through it much easier.

Then we complete the evaluation and testing either at our lab here in Austin, Texas or our lab out in Albuquerque, New Mexico. Or if you have something different that these two labs can’t manage, we have partnerships with other labs in the US and around the world where we can get it done as well. UK and New Zealand specifically come to mind as we are currently working with them this week.

Once this is complete, we will help you edit your documentation. We will give you the boilerplate including the details that you need to go into your manuals. Your manuals must have certain specific information and watch in next week’s video as Steve talks more in-depth about the key features that have to be in your manuals around safety warnings.

We will also help you with the labeling. The nameplate that goes on the back of your product needs to have particular information. We like to use a harmonized worldwide nameplate for larges pieces of equipment. For consumer equipment, we can parse that down very tightly if you like. It is mostly determined by your industrial design and what you want your product to look like.

At this point in the process, you have gotten your product done, your testing done, your evaluation done, and then all the ancillary documentation, labeling, and even stuff that needs to go on the packaging complete.

If you have to iterate anything, then we can help you with the design change iterations as well. We will be there to weigh in on if the possible solutions will work or not and bring the experience of 30 years of doing these types of projects and make recommendations that could work easily. Another key thing to think about is that when we add these safety features or performance features that they work well in the field or factory, so they don’t have to create a work around to manage your safety devices and that they are actually easy to work with, inherent and natural.

Next you receive the finalized documentation and we will send you the product certifications, whether that is in the form of a CE mark, certificate of conformity and declaration of conformity, or FCC, laser for CDRH or whatever your product requires. Or if needed at this point, if we are already working with the lab, we will forward all of this documentation either directly or through you to UL or another lab and complete the project that way.

Moving forward we will preform any kind of reoccurring changes, let’s say for example that you want to do a Model B, C or D that does something different, but has similar features. The work moving forward will be accelerated because we have already worked with your teams, we know the product very well, and we have the data.

This steps you through the process of how we here at High Tech Design Safety (HTDS) gets you from where you are now to certified and to market rapidly, practically, and successfully.

If you have any questions about this process or if you are already working with someone and you have additional questions that aren’t getting answered, reach out to us. We like to help people whether you are a client with us or not. If you are going through a process and you need some advice, just let us know. And sometimes you might find that you are working in a startup or something and doing the early due diligence makes sense, but waiting until you have revenue to do the further certifications makes sense as well. We can help you sort through that as well.