Regulatory Documentation: Navigating the Complexities of Documentation Compliance

Medical Device, Medical Device Safety and Regulation, Medical Device Diagnostics,
  • Thursday, June 13, 2024

Regulatory documentation for medical and in vitro diagnostic device manufacturers has become increasingly complex, specifically with the European Database on Medical Devices (EUDAMED). Incomplete submissions and lack of cohesive structure of technical documentation are the most common reasons for market approval delays, according to notified bodies.

This webinar will explore how a data-driven and componentized approach to content management ensures consistency across data and content, accelerates documentation creation and review and assures compliance of documentation submissions in relation to device registration.

Attendees will learn techniques that will help them work more closely with product data to make content creation and delivery more compliant and accurate and make content an ever more valuable asset for its users.

Register for this webinar today to gain insights into the regulatory documentation requirements for medical and in vitro diagnostic device manufacturers.

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Speakers

André Schlotz, RWS

André Schlotz, VP Global Solutions, RWS

André Schlotz, a graduate mechanical engineer, held various management positions in manufacturing and ICT companies for product development, aftersales, process organization and IT applications before joining RWS in 2013. He has more than 20 years of experience in process consulting, planning, implementation and operation of IT applications, as well as in sales of industry solutions. At RWS, he helps companies to digitalize their content supply chain for regulatory compliance, service, support and customer experiences.

Message Presenter
Jörg Schmidt, RWS

Jörg Schmidt, Senior Solutions Architect, RWS

Jörg Schmidt has been working in multiple roles for different CCMS providers for more than 20 years. During that time, he has helped in defining and implementing solutions in verticals like machinery, automotive, A&D — but also pharma and finance. Since 2013, he has been working for RWS as a Solution Architect.

Message Presenter

Message Presenter

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Who Should Attend?

This webinar will benefit senior professionals from medical and in vitro diagnostic device companies working within:

  • Regulatory affairs and compliance
  • Medical Writing / contributors to Technical Documentation (such as RMP, CER, PMSR and PSUR), SS(C)Ps and IFUs)

What You Will Learn

Attendees will gain insights into:

  • Componentized XML-based structured content authoring compared to an MS Word-based way of working
  • Recognizing the potential of integrating data with content
  • The business value of a component content management system for their organization

Xtalks Partner

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RWS

RWS is the global leader in content management and translation technology and services — 18 of the top 20 global medical devices companies work with us.

With Tridion, our intelligent content platform, enterprises can create, manage and distribute multilingual medical documentation at scale – in compliance with regulations such as EU MDR and IVDR – reducing time to market and cost.

Tridion also enables easy discovery and automated delivery of the right information to the right recipient. As a result, employees and customers gain easy access to the information they are looking for in the moment.

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