MARINETTE — Quality Assembly and Logistics (QAL), a Marinette-based contract manufacturing company which is privately owned by Guy and Sara Meyerhofer, has recently earned the following certifications and qualifications:

¦ ISO 13485-2016, an audit of the company’s quality management system for organizations that design, develop, manufacture, install and service medical devices. The complete recertification audit was completed on June 28, 2017 by SGS Global, an international registrar from the United Kingdom.

¦ Medical Device Directive (MDD) and Canadian Medical Device Conformity Assessment System (CMDCAS). QAL was also audited for compliance during the ISO 13485 audit to the European and Canadian standards. Compliance with all of these regulatory standards allows QAL to conduct business worldwide.

¦ Food and Drug Administration 21CFR 820–Code of Federal Regulations Title 21. This inspection was conducted by an inspector of the U.S. Food and Drug Administration in August. The requirements in this part of the Code of Federal Regulations, are intended to ensure that finished devices will be safe, effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. As a result of the inspection, QAL was found to be in compliance with 21CFR 820.

¦ Finished Medical Device Contract Manufacturer (FMD-CM). As a result of a successful audit conducted in August by representatives of a global healthcare customer, Quality Assembly and Logistics is now qualified as a supplier to perform higher-level repair and service work. QAL will now garner the ability to remanufacture and upgrade medical equipment for the international market beyond the scope of previous levels.