For medical device manufacturers, success depends on cost-effectively maintaining regulatory compliance, driving rapid technological innovation, efficiently documenting quality data, managing product life cycles, and driving higher value to customers. It takes a lot risk management and continuous improvement to remain competitive in the face of these complex requirements.
Medical Device manufacturing companies operate in one of the most competitive – and regulated – industries today. Like many technology, 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 many 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.
This requires more than medical device ERP or Quality Management software.
Sure, Medical Device companies need features like electronic device history records, CAPA, track and trace, recall procedures, learning management, document management, kitting and assembly, warranty and more. But all of these features mean nothing if your people do not accept change and adopt the system; your workstreams are inefficient; the solution is not validated or implemented correctly; or there is no foundation for continuously improving value to customers.
Therefore, it is extremely important that any Medical Device company looking to undertake an enterprise transformation project works with a proven consulting partner with expertise streamlining workstreams, mitigating risk, facilitating organizational adoption, and implementing compliant software solutions.
Merit Solutions enables Life Sciences organizations to transform their business with MAXLife, a robust and pre-configured Microsoft Dynamics AX solution that is deployed in the cloud using Microsoft Azure. MAXLife consists of pre-built business process models, industry-specific documentation, implementation templates, and integrations with top vendors – creating a preconfigured solution that can be “dropped in” with standard configurations or used as an “accelerator” for global deployments.
Learn more about MAXLife for Life Sciences.
Merit Solutions has been working with Life Sciences companies for more than a decade, helping them manage risk, ensure operating performance, maintain compliance, and pursue global growth opportunities. Through our industry-tested combination of front end process consultants, back end technology practitioners, and industry Subject Matter Experts, we have the expertise to enable your successful Life Sciences business transformation.
Our broad range of Life Sciences consulting services and IT solutions help address the challenges related to traditional processes, cultural resistance to change, and less scalable technologies – enabling successful improvement projects while operating in a globally regulated environment.
Life Sciences companies that partner with Merit Solutions typically experience the following results from their investments:
Merit Solutions helps our life sciences clients drive their business, process, and enabling systems changes required to achieve their strategic vision and goals. This includes everything from future state business process mapping to systems analysis, fit-gap process definition and scoping, sourcing, design and deployment, integration with other systems, on-going support, and systems validation.
To deliver optimum customer satisfaction, operational performance, and business success – organizations must be able to provide products and efficiently capture, access, and share operations data in the right way with the right entities.
Becoming a lean organization is not a single step or even a finite undertaking such as a typical project. Adopting lean must be a journey that the entire organization takes as a unit.
Even before you receive your 510(k) approval, you should be using an ERP system to help you develop and document your procedures, track costs, plan materials and monitor product structures.
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