For more information click here to contact us HOME ABOUT US MARKETS PRODUCTS SUSTAINABILITY CAPABILITIES QUALITY NEWS CONTACT US Quality Menu Process Validation Tool Qualification Certifications Quality at Nelipak Nelipak Healthcare Packaging is a quality driven organization committed to supplying products and services to the medical device and pharmaceutical industries that meets or exceeds customers’ requirements. At all levels of the organization, we are dedicated to continuously improving our procedures and processes. Our staff play are an integral part of monitoring and improvement of the quality process. We employ GMP in our production operations for medical and pharmaceutical products. Additionally, we have full product traceability – raw materials, auxiliary materials, inspection results, production conditions and employees involved can be traced for all our products. All Nelipak facilities where products are made, are certified to ISO 13485 for the design and manufacture of custom thermoformed plastic packaging and products to customer specifications. Our quality program meets the stringent standards of medical device and pharmaceutical manufacturers worldwide. Quality assurance is built into everything we do, from order entry to contract review, from document control to training programs, from design control to validation. Key Features • EN ISO 13485 certified • Work according to EU and FDA GMP directives • Automated statistical process control (SPC) system • Bacteriological testing of Class 7 and 8 cleanrooms • On-line inspections that meet MDM standards • Corrective and preventative action (CAPA) and supplier corrective and preventative action (SCAPA) systems • Documentation supporting all of our quality systems Talk to us today! Speak to a packaging professional today about your next project. CONTACT US Nelipak Healthcare is a trade name of Nelipak Corporation. © 2020. Site Map | Privacy Policy I’m looking for Medical Trays Procedure Trays Pharmaceutical Packaging Handling Trays Sealing Machines Learn About The Nelipak Story Markets Design & Development Manufacturing Validations Event Calendar Nov 15 COMPAMED Apr 12 MD&M West 2022 Jun 8 Med-Tech Innovation Expo Nov 2 MD&M Minneapolis