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By Greg Sautter

Serim Research was an early pioneer in the specialty test strip market. Founded in 1988, we were instrumental in developing many of the test strips currently used in dialysis centers around the world.  Our dialysis test strips are used for measuring disinfectant levels (both potency and residual levels) and water quality.  In addition to our dialysis tests, Serim has developed test strips for High Level Disinfection solutions to ensure these solutions are above the Minimum Effective concentration, and tests to ensure that mechanical equipment used for cleaning medical instrument equipment are functioning properly.  In addition to our medical tests, Serim manufactures tests widely used in all aspects of food production industry including production, packaging and food service.  We also manufacture general water quality tests and a diagnostic test for the presumptive identification of H. pylori infections that provides results within one hour. Serim Research Corporation will be in booth S 35

By Salvatore M. Toscano

To improve a one solution answer to sanitizing hands in a globally required sense, BioArmor was brought into the business of infection control.

Science has proven that an alcohol-free option is real, and a 2019 Major Study by the American Journal of Infection Control has certified the better than alcohol option, utilizing the active ingredient benzalkonium chloride a safe FDA approved option since 1950. Our product was purchased by the CDC’s Bioterrorism Task Force Labs, in April of 2014. Now the mission is to present this much needed product to the world. Free of toxins, available to be shipped safely in its non-flammable form and not abused.  Today, in a Covid-19 pandemic world, BioArmor’s new mission is to promote this much needed product globally.

As the pandemic becomes more complex, our new long term growth strategy will include partnership associations to accelerate global humanitarian benefits to keep people safe from farm workers to corporate heads. As BioArmor continues to grow, we have enhanced our infection control product lines to include air purification products with inorganic partnerships, who bring the latest technology to our existing and future markets. This strategy promotes quality of life to a pre-pandemic environment. Meet with Salvatore M. Toscano, CEO BioArmor, LLC at FIME 2022 in the North Carolina Pavilion booth V26 along with Tanner Pharma Group, Floorazzo and 3 more North Carolina Companies.

By John Gargaro

At RAF Solutions USA, Inc., headquartered in Miami (Sunrise), Florida we understand that entering the U.S. market can be challenging and expensive for a manufacturer looking to expand into the US. The complexity and cost of setting up an office and dealing with all the regulatory requirements with the FDA can be a daunting and lengthy process.

We provide help take your needs and turn them into solutions in the areas of:

  • Initial importers/US Agent: Import/Export Requirements, Food and Drug Administration (FDA) Certificate to Foreign Government (CFG).  The FDA require all medical device and IVD companies without an office in the United States to appoint a registered U.S. FDA Initial Importer. The U.S. Importer must maintain a legal office for business in the United States. RAF can serve as an official U.S. Initial Importer for medical device and IVD companies.
  • Regulatory Assistance: Assistance in getting your device through regulatory hurdles so you are able to market in the U.S. and abroad.
  • FDA clearance (510(k), 513(g), and Pre-IDEs and FDA approval (PMA and IDEs)
  • FDA Establishment Registration and Product Listing Medical
  • Official Correspondent and U.S. Agent to the FDA
  • Import and warehousing of your product
  • Full customer service, order fulfillment, and invoicing
  • Inventory control and recall requirements

At RAF solutions, we recognize that setting up in the U.S. and getting the right support and advice can be confusing, daunting, and expensive. That is why we provide an initial cost-effective solution to allow you to enter the U.S. market.  Then we continue to coordinate as you grow, and we scale our solutions to your increasing needs. Come by booth Q68 so that we can discuss your entry and / or grow in the U.S. market.

The 31st Edition of the FLORIDA INTERNATIONAL MEDICAL EXPO will be at the Miami Beach Convention Center, July 27-29, 2022. Register to attend FREE https://fimeshow.info/3vx6Rat Medical Industry updates, with over 118 countries participating. This 32-year-old show is one-stop shopping for “All things medical” FIME is a great place to learn about Industry updates and what is new in data, tech, products, and services.

Here are some videos for FIME 2022 – For event information contact carol.prokap@informa.com

In addition to the over 800 Exhibitors, enjoy complimentary conferences and events

  • Healthcare Transformation Keynotes:

Health Care Transformation Talks are tailor-made for C-suite health care leaders who are leading the transformation and innovation of the health care industry in the USA and Latin America. Navigate new possibilities, the latest scientific discoveries, and cutting-edge technology developments with thought leadership from hand-picked keynote speakers.

  • Innov8 Talks:

We are excited to bring you the Innov8 Talks, a start-up competition that will feature 20 innovative early and middle stage health tech start-ups from across the world, pitching their ground-breaking ideas and battling on stage across three days. The winner will be picked by an esteemed panel of judges which will include industry leaders, investors, government officials and entrepreneurs.

  • Product Showcases and Talks:

The Product Showcases will offer small and medium-sized health care companies the opportunity to showcase their latest innovative solutions and leading-edge products and network with the leading medical devices and equipment manufacturers and distributors in the

 

 

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