A Complimentary CIMdata Educational Webinar with Vinu Gurukar, Executive Consultant, CIMdata
February 13 2020
11:00 EST | 08:00 PST | 17:00 CEST
Every medical device company wants to get to market faster to benefit from the “first-mover” advantage. On the road to commercialization, not everything is within the company’s control. Needless to say, regulatory bodies around the world hold companies accountable to standards and requirements that are getting tougher by the day. As a result, medical device manufacturers have to balance speed to get to regulatory submission and commercialization with the need for regulatory compliance. Regulatory compliance requires “production” and “assembly” of a significant amount of data and documentation during the entire lifecycle of the product. Production and assembly of data take time, effort, and resources, adding cost and extending timelines.
While subject matter experts engaged in the development of new products, features, and functionality are mindful of compliance requirements, they are typically not excited about producing documentation for compliance. So, how do we make the production and assembly of documentation for compliance during product development, manufacturing, distribution, and maintenance less onerous on resources, and free up their time to do more creative work so they can develop more lifesaving products and improve patients’ quality of life? In other words, how can we automate the production and assembly of documents and data for compliance as an effortless by-product of product and process development and manufacturing? The concepts of “digital twin” and “digital thread” can be applied and leveraged to accomplish this, which not only makes it less onerous on resources, but also enables the reuse of data and documentation for the next generation and next iteration product development—thereby accelerating product development.
This webinar focuses on the typical challenges associated with PLM in medical device companies and how they can be overcome.
During the webinar you’ll also have the opportunity to ask questions about the topics discussed.
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