Whether your firm is in the US or not, SMS, Inc. can help you get your medical device to market in the US. We are registered with the FDA as a US Agent and offer services for your regulatory needs. SMS, Inc. draws on a rich background of developmental work on biomedical implants as well as a sound understanding of engineering fundamentals. Thanks to years of living and working in Germany, we speak both technical English and technical German fluently. We understand the cultural differences that sometimes hinder efficient negotiations. As your partner, we are more than an anonymous web site. Make Springfield Metallurgical Services your agent in the US. (Click here for the letter in rich text format.) It's the next best thing to being here yourself.

Consulting

New to the world of FDA regulations? That's where we can help. Perhaps you are a small company negotiating to license your product to a large corporation. We can provide critical information help level the playing field. If you need to protect intellectual property, we can assist in setting up Master Files with the FDA.

510(k) Submission

Currently we offer submissions for Class I and Class II medical devices. We assemble the application and submit it to the FDA on your behalf. You can do as little or as much as you like as far as wording the actual submission goes. If you are a US-client or have a distributor or licensee in the US we will gladly "ghost write" your 510(k) submission. Recent 510(k) submissions include respiratory devices and wound dressings.

Labeling

If English is not your native language, preparing the "labeling" as required by the FDA may not be practical for you. Take advantage of our years of writing reports, technical papers, instructional materials, etc. More than likely SMS, Inc. can do the job both well and economically.

Marketing your Device

Our service to you doesn't end when you get the letter from the FDA granting approval. If the US is unfamiliar territory when it comes to marketing, liability insurance or just about any other need you may have in order to actually sell your device in the US, we want you to think of SMS, Inc. as your partner. Chances are, yours is a small company just like ours, so we understand that you do not have an unlimited budget. SMS, Inc. can help your company grow.