Lighthouse Quality Policy
Lighthouse Tech, Pte. Ltd. is committed to consistently meeting customer requirements and expectations and regulatory requirements by delivering products that meet or exceed relevant quality standards through continual improvement of its products, services, and the QMS.We are ISO 13485:2012 and ISO 9001:2008 certified, as well as FDA registered by BSI under certificate numbers FS 656890 and MD 656889. We have developed an innovative system of spot checks and audits to monitor the quality and conformance for all of our locations and suppliers.
Patent Support
We help you protect your IP with the best patent lawyers in the business.
Design Engineering
Our expert design for manufacturing (DFM) smooths the manufacturing process and reduces long-term cost.
Regulatory Support
We are experienced at helping you navigate the path to your CE mark or FDA approval.
Rapid Prototyping
We provide quick prototype turnaround with 3D printing and machining.
Tooling
With our trusted partners we build quality tooling for consistent and validatable parts.
Cleanroom Manufacturing & Packaging
Starting clean eliminates opportunities for potential failures; we perform molding, assembly, and custom packaging in a cleanroom environment.
Sterilization
EtO provides an excellent sterilization method without causing part degradation.
Global Distribution
We can bring your product to the world with our global network of trusted distributors.
Frequently Asked questions
- Can I visit the factory my project is in, meet the team, and see where my product is being built? Absolutely! We have heard horror stories from our customers about their vendors who won’t let them past the lobby. We understand that you can’t possibly have a good feeling of control over your product/process if it’s being manufactured in a “black box.” The modern regulatory landscape is highly intolerant to this outmoded attitude as well. We encourage all of our customers to come to the factory and participate in the production process, especially during critical milestones such as first articles and validations. If your product is in one of our overseas locations, we will help make your trip easy and comfortable. Of course you don’t have to participate to ensure your projects’ success due to the marvels of modern technology (FedEx, WebEx, emails). There is no need for you to feel disconnected from the process even if you are thousands of miles away.
- Who owns the tooling and fixturing that I make with Lighthouse? If I want to bring my tooling and fixturing in-house at some later date, can I do that? You paid for the tooling, you own it, and you can send it anywhere you like.
- I’m nervous about placing my large project. How can we build trust between our companies prior to moving forward? Let’s chat. Let’s have a video conference. Let’s build the tooling together first and you can see for yourself how easy we make it for you. After all, you can always transfer your tooling to a different location if the process isn’t up to your expectations. Along the way, we are confident in our ability to build trust together for a partnership that will last for many years to come.
- My project is small. Would Lighthouse be interested in working with me? We have worked on all sorts of projects, large and small. We are not confined to projects with high quantity runs and we do not ask for MOQs. We frequently run R&D builds of 5-10 pieces. If you want to make tooling and only run a handful of parts with us, or bring your tooling immediately in-house, we would be happy to work with you.
- Is Lighthouse 9001 & 13485 certified and FDA registered? Will I be able to get a copy of these certifications? Yes and yes.
- Does Lighthouse only manufacture overseas? No. We have an extensive network of well-vetted domestic manufacturers in addition to partners abroad.
- What are the benefits of going overseas? Being flexible about location can often bring your company significant cost savings, faster lead times, and superior expertise in certain areas.
- Will the quality of my product be inferior if it is made overseas? Unfortunately, nonconformance and poor quality manufacturing happens all over the world. Producing your project in a certain country does not necessarily guarantee good or poor quality- it is all about whom you work with! We take quality, conformance, and confidentiality extremely seriously in all of our locations. We are firm believers in the program management model so that there is no diffusion of responsibility- your assigned program manager will be personally involved and responsible for the outcome of your project.
- Will my IP be protected if I choose to place my project in a foreign country?
- We take your confidentiality seriously and value the business position afforded by your IP. Our factories understand that this is the key to our survival as well as yours, and we also only work with suppliers that recognize and respect the criticality of protecting IP.
- How will I know what is happening with my project? Lighthouse prides itself on keeping you in the loop on the status of your project. You will be kept up to date through our online portal which documents updates to your project in real time and which you can log into at any point. You will also receive plenty of pictures and videos documenting the progress on your project.
- Will import duties/shipping costs outweigh the cost savings of going overseas? Will Lighthouse manage the shipping? Typically the costs saved by going overseas outweighs the costs of sea or air freight, however this is not necessarily the case for very heavy or large items. Shipping costs and logistics will definitely be taken into consideration when helping you choose our best manufacturing location that makes the most sense for your project. Many foreign manufacturers have “ex-works” incoterms/do not participate in the shipping process. Working with our partner freight forwarding company, Lighthouse is happy to support your shipping needs at no cost to you.
Please tell us about your project today!
