Lincoln, NE – HTI Plastics, a world leader in injection molded plastic parts, has been producing pharmaceutical applicators in the feminine hygiene market for over thirty (30) years. For a majority of 2023 our quality and engineering departments worked diligently on our companies EU MDR (European Union Medical Device Regulation) submission to obtain the certification to sell CE and CA devices in to the European and United Kingdom markets.
“Gaining our certification against the MDR 2017/745 regulation is a great and important achievement for ourselves and our customers as our supply chains continue to reach more globally,” said Ford Earhart, Quality Manager at HTI Plastics. “This certification demonstrates the high level of regulatory competency and quality system maturity at HTI Plastics. We are now in a position to better serve those companies looking to move into the European Union and United Kingdom with medical device product that meets the full Health Authority requirements for this market.”
By obtaining our MDR certification, HTI Plastics has shown that we as a company follow the strictest standards and regulations for product quality, safety, processes and performance. Already holding ISO 9001:2015 and ISO 13485:2016 certifications, HTI Plastics has shown we are a leader in quality and performance standards in not only our products, but our processes.
The fast pace in which HTI Plastics received our MDR certification validates our commitment to quality. Holding a MDR certification for CE and CA devices in the European and United Kingdom markets opens HTI up to offer our top-of-the-line pharmaceutical products to more companies in the EU and UK, as well as companies in the United States and other regions wanting to sell into those markets.
ABOUT HTI PLASTICS
Since 1985, HTI Plastics has provided high-quality injection-molded plastic parts to customers in the U.S. and overseas, with a strong focus on both responsive expertise and exceptional value. HTI’s knowledgeable team is dedicated to working in partnership with customers to provide innovative solutions and timely deliveries in an atmosphere of continuous improvement. For more information, visit htiplastic.com.
PCE Inc., a privately held corporation founded in 1993, is structured two business groups serving the plastics industry. HTI Plastics providing injection molding services and Lincoln Plastics providing plastic profile extrusion services. PCE, Inc. does business in six continents with solutions for every size of company. www.pce.us.com
