Medical Device Assembly – and Medical Contract Manufacturing in general – are fields that are completely dependent on quality and precision. There is no margin for error in anything designed and produced for the Medical industry.
At MME group we engineer and manufacture products that are regulated by the FDA including 510(k), and class I and class II devices. Our facilities feature class 8 (100,000) clean rooms for molding and assembly of medical devices and parts. We complete rigorous onsite testing and validations, and maintain our own unfailingly high standards for quality.
MME group’s dedicated engineers and quality management team ensure that your internal compliance and documentation needs are met, and will assist in preparing and compiling data for your FDA submission.
We understand the advantages and complexities of offshore manufacturing and exercise complete supply chain management to help reduce costs.
We are ISO 13485:2012 and ISO 9001:2008 certified, ITAR and FDA registered.