Mayo Manufacturing Management, Inc. (Mayo) provides consulting, training and related contract support services to client organizations in the following:
ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
ISO 13485 defines quality management requirements for manufacturers of medical devices. Key focus on process controls, compliance and safety. It is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. A primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems throughout the world. It is recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements. Key areas of the standard are design controls, manufacturing controls, quality assurance and risk management.
21 CFR 820: Code of Federal Regulations title 21 - Quality System Regulation
21 CFR 820 is the US Quality System Regulation for medical device manufacturers who sell products in the USA have a legal requirement to comply with 21 CFR Part 820 of US federal law. Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Much of the regulation is comparable to ISO 13485 with more prescriptive details as to the compliance requirements for organizations.
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