Marinette, WI, September 27, 2017 —- Quality Assembly and Logistics (QAL), a Marinette-based contract manufacturing company which is privately owned by Guy and Sara Meyerhofer, has recently acknowledged 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 ISO standard places significant emphasis on regulatory requirements, risk management and mitigation and regulatory requirements which ensures that process controls are in place to guarantee the highest standards of quality and repeatability. While the primary objective of ISO 13485 certification is to facilitate harmonized Quality Management System requirements for regulatory purposes within the medical device sector, companies also value this certification for the increased confidence that it provides patients and other stakeholders through the implicit promise of quality, consistency, and continuous improvement. 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 US Food and Drug Administration in August 2017. This inspection was similar in scope to the ISO 13485 audit. An exhaustive evaluation of the Quality Management System with emphasis on (cGMPs) Current Good Manufacturing Practices. The requirements in this part govern the methods used in, and the facilities and controls used for, the engineering changes, manufacturing, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. 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, 2017 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. Achieving the highest level of certification, QAL will now garner the ability to remanufacture and upgrade medical equipment for the international market beyond the scope of previous levels.
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