Regulatory Compliance

Managing regulatory compliance in medical device development with IBM Engineering solutions

Healthcare, life sciences and medical device industries are facing unpredictable market changes, global competition, and constantly evolving regulatory mandates and guidelines. To remain viable and competitive, corporations must balance rapid innovation with compliance mandates that dictate safety and effectiveness. The necessity to innovate and evolve the business in order to leverage new technologies such as biologics, advanced drug treatments or software‐enabled medical devices while maintaining compliance requires organisations to undergo significant business process and development life cycle transformations. Medtech manufacturers have expressed concerns that the processes dictated by the broad and evolving governmental regulations and guidelines such as FDA, GMP, EU MDR, IVDR and others negatively impact their time‐to‐market and increase the overall development time.

The IBM Engineering solutions for systems and software engineering can assist with reaching compliance goals through integration, collaboration, automation and reporting in a more efficient way. The presented solutions provide a core set of best‐in‐class tools and processes for systems and software engineering teams, facilitating engineering collaboration with unprecedented high level of transparency of project progress, control of artefacts, and traceability. 

To explore how the IBM Engineering Lifecycle Management solution can help you to comply with FDA or EU regulations and guidelines as well as safety and quality standards such as IEC 62304ISO 13485 and ISO 14971 read these articles: 

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IBM

Managing regulatory compliance in medical device development with IBM Engineering solutions

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IBM

Engineering Solutions for Medical Devices

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