Medical device regulations are soon to be imposed in Europe and only less than one-third of medical device manufacturers are aware of the regulations in deep. The current MDD will be replaced at the companies will now have to demonstrate about all clinical evidence regarding the safety of class III devices. Compliance to regulations seems tough as the existing technology with manufacturers is outdated but this also can be seen as an opportunity for manufacturers to upgrade their technology to the latest and keep up in the competition. To MDR compliance manufacturers will now have to maintain system and documentation throughout device lifecycle and to accomplish this, various other tasks are required such as risk management, clinical evaluation, post-market surveillance and clinical studies for which technology will be a helpful hand.
Cloud-based solutions will provide businesses with a framework that will more collaborative and transparent in document and data management. The cloud solutions are capable to remove silos between departments and provide agile communication within the organizations and as well as with external organizations. Document lifecycle will also increase with digitization and ease of access will be a part of the system as employees will be operating from anywhere outside the company.
Medical devices regulations demand perennial lifecycle of documents with complete details about them including manufacturing details to safety measures which require a lot of paperwork and their maintenance throughout the lifecycle is costly but cloud-based solutions are potent to maintain and record large volumes of documents and data without any hassle and that too with complete security. These platforms make data sharing and retrieval more agile and convenient than before.
Time and money saved from document cloud-based solution will enable organizations to focus on their technology for building medical devices and improvise them as required for MDR. Processes such as device testing will gain efficiency resulting in better quality products than before. Several benefits that cloud will offer in document management would be-
• Secured Storage
• High Computational Power
• Database as a Service
• Authentication Service and Security Tokens
• Specialized DNS routing for a locality
• Scaled, distributed, and internodes communication facility