Medical Device Consulting Services and Software Solutions
In order to maintain compliance and a competitive advantage, Medical Device companies need to be lean and effective;
transparent and controlled; agile and responsive.
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.
MAXLife for Life Sciences
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.
Why Merit Solutions?
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:
Reduced Compliance Costs
Merit Solutions helps Life Sciences companies define a compliance strategy, designing the preventative, data integrity, and significant process controls required to carry out and efficiently operate your enterprise compliance strategy. Along with our partners, we help clients deploy validated systems that have effective change management built in to support the changing needs of your company moving forward.
Reduced Operating Costs
The biggest cost of manual processes is people. It costs companies time (money) by manually performing tasks that can and should be automated and streamlined. Automated systems and processes also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. And the eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.
Increased Ability to Rapidly Scale
When you grow, you have increased volumes going through your business work streams, and increased variations in those work streams coming from different types of customers, order, products, suppliers, and partners. Merit will help you remove the disorganization potential of paper-based and manual work streams, eliminating risk and impediments to your rapidly growing company.
Faster Innovation and Reduced Cycle Times
Significant increases in the volume and complexity of internal and external business data provide growing challenges when locating, retrieving, sharing, processing, and distributing that information. We help companies enforce the consistent execution of processes while providing an accurate, real-time view of critical data to those who need it.
Improved Decision Making
Merit helps clients eliminate the time delay in getting accurate, consistent, and usable information that comes from manual and paper-based processes. By implementing work streams and information flows that connect your activities in the most efficient manner for delivering customer value, we are also enabling real-time access to the most important information the company needs for business decision making.
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.