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Created in 1979 by 31 members of AdvaMed, Medmarc’s mission is to be the superior provider of liability insurance and related risk management solutions. We support the research and development, manufacturing, and delivery of medical products that save lives and improve the quality of life. From ideas and prototypes to the reality of commercialization and success – We Can Meet Your Changing Needs. Contact us to discuss what insurance coverages are needed for your business plan. www.medmarc.com
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At SGS, we help medical device clients ensure their products are consistently of highest quality and meet regulatory requirements. We are a Notified Body for medical device CE marking through our Belgium affiliate (1639), and in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) products. SGS is a UK Approved Body (0120) for the UKCA scheme for Great Britain as well as an Auditing Organization (AO) for MDSAP certification. www.sgs.com | |
 |  | Steri-Tek, based in Fremont, CA, with a new facility in Lewisville, TX is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries. Steri-Tek is an ISO 11137 and ISO 13485 certified, FDA registered, DEA licensed as well as State of California Medical Device and Drug Manufacturing licensed facility. The California facility boasts two state-of-the-art 10 MeV, 20 KW linear accelerators. The Texas facility utilizes two state-of-the-art 10 MeV, 30 KW linear accelerators. Both offer simultaneous beam processing that allows for high volume production, providing uniform dose to the product without having to rotate the customer’s boxes. This DualBeam™ configuration significantly increases efficiencies, expands product options, and serves as an effective back-up for the accelerators. Steri-Tek has developed a proprietary system for radiation sensitive materials such as drugs/biologics, combination devices, bioabsorbables, implantables, advanced polymers and other complex products. Steri-Tek offers:
- Turnkey Validation Services (per ISO 11137 VDmax and Method I)
- Rapid Turnaround on Routine Sterilization Processing (48 hours standard with RUSH 24 hour and 4 hour turnaround available)
- DualBeam™ E-beam/X-ray processing (Highest up time in industry)
- Expert Consultation Services to optimize E-beam/X-ray sterilization processing and throughput of complex devices
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FloridaMakes is a statewide, industry-led, public-private partnership operated by an alliance of Florida's regional manufacturers associations and partner organizations with the sole mission of strengthening and advancing Florida’s economy by improving the competitiveness, productivity, and technological performance of its manufacturing sector, with an emphasis on small and medium-sized firms. It accomplishes this by providing services focused on three principal value streams: technology adoption, talent development, and business growth. FloridaMakes is the representative of the Manufacturing Extension Partnership (MEP) National Network in the state of Florida, a program of the National Institute of Standards and Technology, an agency of the U.S. Department of Commerce. For more information about FloridaMakes, visit www.FloridaMakes.com and follow @FloridaMakes.
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Covington is a pre-eminent international law firm with more than 1,300 lawyers and advisors across 14 global offices. We offer one of the largest and most comprehensive life sciences industry-focused practices in the world. Our Medical Device Industry Group integrates the firm’s extensive regulatory, transactional, litigation, and intellectual property experience to meet the specialized needs of our clients with a commitment to the highest professional and ethical standards. www.cov.com
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Adams’ is a multi-faceted resource in the medical device industry. Our team of experts can assist with component and sub-assembly selection within medical devices for pneumatic, fluid or motion control applications. In addition, Adams offers engineering and design assistance for factory automation, machine vision, and robotics aimed at increasing productivity in your manufacturing facility, exemplified by our inline tubing and wire inspection platform. www.adamscorp.com
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At BSI, we understand the challenges manufacturers face in bringing compliant products to market efficiently with absolute safety for patients. To help overcome these challenges, we offer a range of comprehensive and proven regulatory services, including UKCA, CE Marking, Medical Device Regulation, and In Vitro Diagnostic Regulation. We strive to set the global standard by conducting impartial, responsive, and robust conformity assessments, evaluations, and certifications that are recognized and trusted worldwide. www.bsigroup.com
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Freudenberg Medical is a global partner for the design, development and manufacture of medical devices and components that play a critical role in medical and pharmaceutical applications. With 11 manufacturing operations worldwide, Freudenberg Medical offers a wide range of capabilities from complex catheters, hypotubes, steerable shafts, handles, balloons, and coating solutions for minimally invasive products to advanced extrusions and precision molded components in both silicones and thermoplastics. Your medical device in safe hands with Freudenberg. www.freudenbergmedical.com
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Hallmark Nameplate operates from a 30,000+ square foot facility in the heart of Central Florida. Our engineering and manufacturing expertise spans over 60 years and includes thousands of products for the medical, aerospace, computer, telecommunications, and OEM industries. In addition to our custom nameplates, membrane switches, and product identification services, we offer extensive capabilities for complete electronic assembly. We are proud to be a small, Veteran-led business dedicated to craftsmanship and satisfied clients. We infuse quality into every step of the process. We like to say that we are small enough to react but large enough to deliver—and our customers would agree. We look forward to working with you. www.hallmarknameplate.com
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NABI specializes in comprehensive biocompatibility and chemistry testing for medical devices according to ISO 10993 standards. With expertise in FDA and MDR requirements, our services include also: microbiology and sterility; cleaning, disinfection, and sterilization validations; package validation; and toxicology. Our facilities are GLP certified, US FDA 21CFR58 compliant, and ISO 17025 accredited. With over 20 years of experience, our experts optimize testing to minimize customer expenses. We are a proud member of AAMI. www.nabi.bio
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NDH Medical is a custom extruder of tubing for the life sciences industry and a full service contract manufacturer of single-use medical devices. Single and multi-lumen tubing, taper (bump) tubing, braid reinforced tubing, co-extrusions, coil and wire jacketing, and paratubing are produced in a wide range of medical grade thermoplastics. Contract manufacturing services include injection molding, insert molding, assembly, tip forming, hole punching/drilling, printing, packaging, sterilization and inventory management. NDH Medical is ISO 13485:2016 certified and FDA registered. www.ndhmedical.com
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Hill Ward Henderson is a full-service law firm with over 120 attorneys, serving a wide range of local, regional and national clients spanning a broad variety of industries and professions. Our services include: Appellate, Bankruptcy & Creditors' Rights; Construction & Design; Corporate & Tax; Cybersecurity, Data Breach and Protection; Employment Law; Executive Compensation & Employee Benefits; Healthcare; Intellectual Property; Land Use; Litigation; Products Liability; Real Estate; and Trusts & Estates. For additional information, please visit: www.hwhlaw.com
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International Sterilization Laboratory (ISL) offers EO Sterilization used by the Medical Device industry to sterilize disposable medical devices. We are strategically located in Central Florida, staffed by a team of seasoned sterilization professionals.
www.isl-fl.com
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James Moore is a business consulting firm offering a vast array of customized services for manufacturing clients nationwide. We offer traditional accounting and specialized tax services such as R&D credits, cost segregation, sales tax, and state income tax compliance. We also offer advisory services in human resources, IT, and CFO services, providing bold solutions that help manufacturing businesses and all our clients grow, build value, and thrive. www.jmco.com
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LGGS is an independently contracted laboratory specializing in U.S.P. and ANSI/AAMI/ISO microbiological testing. At LGGS, Inc., we understand the challenges presented by a changing marketplace. We emphasize accuracy, reliability, and the fastest turnaround time of our results. Our highly dedicated professional staff is there to watch your product closely and communicate abnormal occurrences to you directly. www.lggsinc.com
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 | | IMT Analytics is a world leader in the manufacture, distribution, and service of gas flow analyzers. These high-precision medical class I gas flow and pressure measurement instruments are capable of testing a wide range of medical devices such as respiratory and anesthesia machines, oxygen flow meters, pressure gauges and suction devices. We also offer test lungs for cost-effective and safe verification of ventilators and anesthesia machines for functionality and precision. In addition, IMT Analytics offers easy to use comprehensive PC software for our biomedical testing devices. Our industry leading EasyCal calibration service makes it convenient for our customers to send their instruments for annual maintenance and calibration. Our ISO 13485 certified quality management system and our sophisticated ISO 17025 accredited calibration laboratory ensures the highest quality standards. Since 1999, our brand has been well known globally for dependable, high-quality products and services. With our headquarters in Switzerland, a satellite office in Singapore, and a brand-new sales and service facility in St. Petersburg Florida, we have been selling our products through our worldwide network of partners and distributors. www.imtanalytics.com
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IMT, a leading Swiss engineering company with over 30 years of experience, provides comprehensive end-to-end engineering solutions for medical device manufacturers. Specializing in product development, testing, and regulatory compliance, our multidisciplinary team uses advanced technologies like artificial intelligence, rapid prototyping, and simulations to create high-quality, reliable medical devices. With a proven track record in various clinical fields such as respiratory medicine, anesthesiology, and microsurgery, we ensure the highest standards of safety and performance. Our in-house regulatory team expertly navigates global medical device regulations, facilitating successful product registration and market entry for medtech companies and OEMs. Partner with IMT to seamlessly transform concepts into innovative, market-ready medical products. www.imt.ch
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Oliver Healthcare Packaging is a leading supplier of pouches, lidding, roll stock, and mounting cards for the global healthcare industry. The company's packaging protects medical devices, pharmaceutical products, and the like throughout the sterilization, shipment, and storage processes. Headquartered in Grand Rapids, Michigan, and with global manufacturing, Oliver is ISO 13485 certified. Visit us at www.oliverhcp.com.
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Formed in 1987, the Pasco Economic Development Council (Pasco EDC) is the lead economic development organization dedicated to the overall growth and prosperity of Pasco County through the development of a sustainable and diversified economy. Pasco EDC is a private, non-profit organization that promotes countywide economic development and continues to be a strong partnership funded by corporate and public investors focused on the economic vitality of Pasco County. Pasco EDC is committed to positive growth to make Pasco County a great place to live and work. You won’t find a more supportive county in which to do business. www.pascoedc.com
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SteriPack Group provides world leading contract manufacturing solutions, underpinned by holistic and integrated product life-cycle management solutions, allowing our customers to unlock new levels of growth. Offering Product Design & Development, Cleanroom Injection Molding, Complex Cleanroom Assembly, Form Fill & Seal as well as Rigid Tray & Pouch Filling/Sealing capabilities, SteriPack can service every step from concept to commercialization. www.steripackgroup.com
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Pro-Tech Design & Manufacturing, Inc. is an ISO 13485 certified packaging, assembly, and sterilization contract manufacturing organization. Our services include packaging design, pre-validated and custom packaging, Class 10,000/ISO 7-rated cleanroom assembly, sterilization management, labeling, and distribution. We also design and produce sewn medical wearables for customers. Our sterilization management services include managing EO and gamma sterilizers to process full pallet loads, and our own, in-house steam sterilizer. We also have an in-house, ISO 17025 certified laboratory for packaging validations. We are woman-owned and offer convenient locations in Minnesota, Southern California, and Texas. www.protechdesign.com
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Indus MedTech Solutions is a boutique medical communications company providing personalized medical and regulatory writing solutions. Our team consists of advanced degree professionals with 10+ years of experience preparing scientific, clinical, and regulatory documents for medical device manufacturers. Our past clients include several Fortune 500 companies and small to mid-sized device manufacturers. We are committed to customer satisfaction and delivering results that exceed our clients' expectations. www.indusmedtechsolutions.com
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Key Packaging provides high quality custom thin gauge thermoforming plastic packaging solutions to a wide variety of industries; including medical device packaging, automotive trays, pharmaceutical packaging, cosmetic packaging, retail packaging, electronic packaging & food packaging. With over 40 years of package design and manufacturing expertise our highly skilled personnel combined with our state-of the-art manufacturing equipment and production facility makes Key Packaging a clear leader and your key partner for custom thermoforming. www.keypackaging.com
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Bank of America is one of the world’s leading financial institutions, serving individuals, small- and middle-market businesses, large corporations, and governments with a full range of banking, investment management and other financial and risk management products and services. Our purpose is to help make financial lives better through the power of every connection. We deliver on our purpose by driving responsible growth, delivering returns to our clients and shareholders and helping address society’s biggest challenges. www.bankofamerica.com
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