Register for this webinar for a virtual panel discussion of some of the critical questions being asked about medical device requirements for global health authorities with special emphasis on EU EUDAMED. The panel will discuss topics like:
- What should I know about existing CE marking and future requirements?
- For IVDR, who decides what class a product falls into and can I ‘self-certify’ under the IVDR?
- Are there some products that have resulted in reclassification to a ‘higher class’ for EU-MDR, what are some examples?
- When the UDI/Device Registration Module opens, will EUDAMED already be populated with existing ‘Directive’ device info? If I participate in the voluntary period, does that count as an ‘official’ submission or do I re-submit when EUDAMED goes live?
- For EUDAMED device registration, what is the difference between Regulation and Legacy requirements?
- What Quality Management changes need to occur to comply with MDR/IVDR?
- What are the main differences between GMDN and EMDN? Is mapping available between the two standards?
Bring your questions. We will also review the global regulatory health authorities and their timelines for requirements.
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
John Lorenc, Director Product Management, Medical Devices, Reed Tech
John Lorenc directs electronic submission and regulatory requirement initiatives that impact the medical device industry. He has advanced experience with machine-to-machine submission requirements to global UDI databases, including US FDA GUDID, EU EUDAMED, and China NMPA UDID. John represents Reed Tech in membership with MedTech Europe, and actively participates in electronic submission pilots to regulator UDI databases.
Mark Wasmuth - CEO, The GMDN Agency
The Global Medical Device Nomenclature (GMDN) is a list of generic names used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The main purpose of the GMDN is to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety.
The GMDN is used for:
- Data exchange between manufacturers, regulators and healthcare authorities
- Exchange and analysis of market surveillance and vigilance information
- Supporting inventory control in hospitals
- Purchasing and supply chain management
Learn more – GMDNagency.org
Tom Rish - Medical Device Guru, Greenlight Guru
Tom Rish is a Medical Device Guru at Greenlight Guru who works with customers to utilize their QMS software to build safer products on expedited timelines. He is a biomedical engineer who began his career developing implant and instrument systems in the orthopedic industry. He enjoys helping medical device companies successfully navigate regulations across global markets as they bring life changing technologies to market.
Learn more – For a personalized demo of QMS software for medical devices: [email protected] +1-317-960-4220
Erin Salbilla, Director of Quality Systems, Vyaire Medical
Erin Salbilla is an experienced QRA Director with a demonstrated history of working in the medical device industry. She is skilled in Quality Systems compliance, harmonization and remediation; Medical Device Labeling; Global UDI requirements and compliance; EUDAMED; and EU MDR Compliance.
Who Should Attend?
- Global Strategy Business Managers
- Regulatory Affairs/Operation Leaders
- Product Managers and Business Analysts
- Manufacturing, Operations and Supply Chain Leaders
- Quality Leaders
- IT Support
What You Will Learn
For regulatory teams working on EU MDR/IVDR data, this webinar will be a helpful walk-through of the main takeaways in the published information from the European Commission and the Medical Devices Coordination Group concerning current state and future.
Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.
Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.