The complex and constantly changing regulatory environment has made correct master data a growing imperative for many medical device and technology companies. The importance of master data in the regulatory compliance cannot be over emphasized. During pre and post market approval master data management can help medical technology companies meet regulatory challenges and reduce compliance risks.
Let’s look at each of those processes in detail.
Pre-Market Medical Device Approval
Master data management facilitates the pre-market approval process by tracking current regulations and providing essential information. It can support the process of listing and registering facilities by providing information about the location of manufacturing sites. It can also help companies establish and monitor a quality management system by providing information on device components, supply chain, the manufacturing process, hardware and software service contracts, and any recent requirements for device design, labeling, storing and installing.
Master data management could also considerably reduce the time and costs related to completing the application procedure by providing accurate information and accelerating certification processes.
Post-Market Medical Device Approval
Master data management can also considerably reduce regulatory compliance risks in post market approval by keeping track of changes in regulations and providing current and correct device-specific information. Information such as hardware, components, and tracking of the medical device changes and maintenance, including service history and support incidence can be streamlined as part of the master data management approach
Additionally, master data management can cut reporting costs by automating and streamlining the report submission processes for regulatory organizations. By providing recent and accurate information, master data management accelerates the recertification process.
Technology is important when using master data to support successful compliance, but it isn’t enough. Processes and people must be aligned to the broader master data management approach and the regulatory submission process is effective and efficient. Achieving regulatory compliance depends critically on having a data governance model with clearly defined processes, roles and responsibilities in place. If you can achieve this, you can use master data management to take a proactive rather than a reactive approach to regulatory compliance.
In the current global business landscape, medical technology companies must look at master data management as an imperative for business success. By decreasing the master data complexity organizations will establish a single, trusted, and consistent data source that informs processes and decision making, drives competitive advantage, and enables them to pursue strategic initiatives with greater confidence. Only by having accurate, consistent and up to date master data will businesses meet the complex challenges of a globalized world and ever-increasing regulations.