Case Study : EU MDR Recent Engagements Delivering in Partnership with Client teams Industry Medical Device Manufacturer – Global BU Regulatory Background/ goals ? Working assumption was that the business was compliant to the current MDD (Medical Device Directive) and we assessed the business against the full requirements of the new EU MDR Project approach ? Initiated the program with a 2 day workshop with the combined business stakeholder teams. We had 3 objectives for the workshop, 1. to education the teams in the regulations by conducting a ‘top-down’ assessment of the impacts of the legislation on the product portfolio and key aspects of the business operations including multiple QMS, Post Marketing processes and a complex EO Network. 2. to develop an initial view of the pote

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