Medical device manufacturers operate in an increasingly regulated, safety-critical environment, and frequently have many variants of parts, products and product lines. It is, therefore, necessary to identify, estimate and evaluate your device risks at the right time to increase the quality and safety of the device, and to motivate the project members.
Having an effective risk management process adds value by decreasing the project risks and avoiding costly late-stage changes. Furthermore, a risk management process is also mandated by regulatory authorities in the US through the FDA CFR 21 Part 820, the updated European EU MDR/EU IVDR and the MDSAP, which covers markets such as Canada, Brazil, Australia and Japan.
There are several aspects of implementing an effective risk management process. A recommended first step would be to establish a risk management process including usable and operational templates so that the process complies with ISO 14971:2012 for the European market and ISO 14971:2007 for the rest of the world.
This webinar will provide attendees with some tips on implementing — or improving — the risk management process.
It will also address the way in which robust system behavioral modelling can be integrated with downstream risk management practices to produce better, safer products. It is intended, through discussion of the latest advancements in system-level thinking, to help inform senior engineering professionals responsible for the cross-discipline lifecycle of their products.
Jennifer Moore, Business Development Director, Minerva Group
Jennifer Moore has more than 15 years of experience in Business Transformation across various industries including medical device.
She is an entrepreneurial thinker with extensive experience in developing and deploying large, multi-faceted enterprise software projects, leading cross-functional teams, navigating sophisticated environments, and driving revenue as well as market adoption.
Oliver Dick, Customer Relationship Manager
Oliver Dick combines several years of experience in the field of product lifecycle management (PLM) software in a regulated environment with a deep knowledge of the global medical device industry. He is an engineer by training and has engineer working experience from medical device companies such as Dräger, Pulsion and Olympus Surgical Technologies. His specialties include best practices on verification engineering and regulatory compliance.
Thomas Skogen, Product Director, Minerva Group
Thomas Skogen brings experience from his background in supply chain and manufacturing optimization, where he has helped several global companies optimize their internal and external business processes. Thomas’ experience originates mainly from the electronics & high-tech and medical device industries. This combined with his experience within all levels of PLM implementations provides a solid foundation for his current role of managing customer engagement and development of Minerva’s product range targeted towards electronics & high-tech and medical device industries. Thomas comes with a background as an electronics engineer, complemented with a Master’s in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization programs as well as the supply chain organization.
Christoph Golinski, Senior PLM consultant
Christoph Golinski has more than 15 years of experience in consulting for PLM solutions in the medical device, aerospace, electronics, high-tech and renewable energy industries. His knowledge spans the disciplines of configuration management, requirements engineering and PLM data quality management. His fascination of PLM software is visible, and he could talk about it for hours. The range of requirements and the tools used in a manufacturing company is wide and almost everything is included in a PLM software system, from complete in-house developments to open source. The character of the product data and the business processes vary from heavily regulated industries to less regulated industries, but both will benefit from being managed in a PLM system. In short, PLM is and remains the backbone of every industrial company.
Who Should Attend?
This webinar will appeal to directors and other senior-level professionals of the medical device industry working in:
What You Will Learn
Attendees will learn:
- How to improve efficiency in controlling and managing complex data structures
- How to secure and improve traceability
- How to improve visibility and processes
- How to secure a complete audit trail in one system
Minerva Group is one of the most established vendors of Product Lifecycle Management software solutions for the medical device industry. Our industrial solutions and add-ons for the Aras Innovator software platform help our clients to speed up the implementation process. With Medical Device PLM, we support medical device manufacturers to optimize their processes, projects and information management by handling everything concerning the product, from cradle to the grave. Read more at www.minerva-plm.com or www.medicaldevice-plm.com.