Medical Devices Manufacturing

Medical Device manufacturing companies operate in one of the most competitive – and regulated – industries today. Like many technologies, electronics, and device manufacturing organizations, success in the Medical Device industry depends on a company’s ability to produce the highest quality products faster than the competition. Unlike other industries, however, Medical Device manufacturers must meet some of the most stringent government and customer compliance regulations regarding documentation, controlled processes, and product safety.
Maison understands and helps deliver solutions with FDA compliance, engineering change orders (ECO), engineering change requests (ECR), manufacturing change orders (MCO), manufacturing change requests (MCR), document management (PDM), electronic signature, complete audit trails, device master and history records and full life cycle after sales service and support. Maison’s experience in medical device manufacturing supports the entire product development, production, sales and support, beginning with engineering to stock and engineering to order processes, retaining version controlled design documents to track the history of the design process. Using the same change request and change order workflows, our advice in business solution implementation can help improve the product design, production and after sales support by giving users an integrated framework and a clear view of the product development history.
Maison Domain Experts and Industry Partners help Medical Device companies demonstrate that they meet the processing, safety and tracking standards required by law. The software recommended and services provided by Maison can help reduce the time and effort required to maintain FDA compliance and enable Medical Device manufacturers to focus more time and effort on producing the highest quality products – and speeding time-to-market.