Innovation et gestion de programmes synchronisée et collaborative pour les nouveaux programmes
Aérospatiale & Défense
Innovation et gestion de programmes synchronisée et collaborative pour les nouveaux programmes
Explorer l’industrieAutomobile et Transports
Integration of mechanical, software and electronic systems technologies for vehicle systems
Explorer l’industrieBiens de consommation & Distribution
Innovation produit grâce à la gestion efficace et intégrée des formulations, du packaging et des procédés de fabrication
Explorer l’industrieÉlectronique & semi-conducteurs
Le développement de nouveaux produits exploite les données pour améliorer la qualité et la rentabilité tout en réduisant les délais de mise sur le marché et les coûts.
Explorer l’industrieÉnergie et services publics
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assets
Explorer l’industrieHeavy Equipment
Construction, mining, and agricultural heavy equipment manufacturers striving for superior performance
Explore IndustryConstructions mécaniques et équipements lourds
Integration of manufacturing process planning with design and engineering for today’s machine complexity
Explorer cette industrieInsurance & Financial
Visibility, compliance and accountability for insurance and financial industries
Explore IndustrySecteur maritime
Innovation dans la construction navale pour réduire de façon durable le coût de développement des futures flottes
Explorer l’industrieMedia & Telecommunications
Siemens PLM Software, a leader in media and telecommunications software, delivers digital solutions for cutting-edge technology supporting complex products in a rapidly changing market.
Explore IndustryAppareils Médicaux et Produits Pharmaceutiques
« Innovation produit personnalisée » grâce à la digitalisation, pour répondre à la demande du marché et réduire les coûts
Explorer l’industrieSmall & Medium Business
Remove barriers and grow while maintaining your bottom line. We’re democratizing the most robust digital twins for your small and medium businesses.
Explore IndustryFDA/CDRH Officials Present First-Hand Advice: How to Weave a Digital Thread that Advances Patient Safety
FDA/CDRH Officials Present First-Hand Advice: How to Weave a Digital Thread that Advances Patient Safety
How to weave a digital thread that advances patient safety
Watch this webinar to learn how, in response to the COVID-19 pandemic, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) collaborated with Siemens Digital Industries Software to explore the application of advanced digital design and manufacturing technologies to improve production agility and resume safe manufacturing operations.
This presentation will feature several use cases and emphasize how a digital thread approach has the potential to transform the way manufacturers design and manufacture medical devices, and how they interact with regulatory agencies.
Daniel Walter
Case for Quality Project Lead, US Food and Drug Administration
Daniel Walter is a member of the compliance and quality staff in the FDA’s Office of Product Evaluation and Quality’s Immediate Office of the Center for Devices and Radiological Health (CDRH). He is currently the Project Lead for Case for Quality, which is an ongoing strategic priority for CDRH, aimed at improving patient access and outcomes, and medical device quality. His background includes being a compliance officer in the CDRH’s Office of Compliance’s Vascular and Circulatory Support Branch; chief of the Foreign Enforcement Branch in the Division of International Compliance Operations overseeing medical device manufacturers; and additional regulatory and industry roles.
Francisco Vicenty
Program Manager, Center for Devices and Radiological Health, US Food and Drug Administration
Francisco (Cisco) Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. This follows roles as branch chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality within the Office of Compliance; as compliance officer in the Cardiac Rhythm and Electrophysiology Branch in CDRH’s Office of Compliance at CDRH; and as a quality and reliability Engineer with IBM’s Micro-Electronics business unit.
Bleta Vuniqi
Team Lead, Quality and Compliance Staff, US Food and Drug Administration
Bleta Vuniqi is a Team Lead within the Quality and Compliance Staff in OPEQ/IO. Bleta has been with the FDA since 2010. Previously, Bleta was the Quality System Specialist within DMQ/OC, and Senior Program Expert in OPEQ/ORP/D1 focusing on PMA policy and process improvement. She previously held a biomedical engineering role within the Respiratory, ENT, General Hospital and Ophthalmic Device Branch in OC where she conducted post market activities regarding these devices and provided regulatory advice in making decisions and resolving regulatory conflicts. Before joining CDRH Bleta was an FDA investigator in ORA responsible for conducting medical device inspections and investigations. She graduated from Wayne State University with a Masters in Biomedical Engineering and Bachelors in Chemistry.
Christopher Brown
Acting Senior Consumer Safety Officer, US Food and Drug Administration
Christopher holds a B.S., and Graduate Certificate in Mechanical Engineering from the University of Maryland, and M.S in Technology Management from University of Maryland University College. He has the following Certifications: Medical Technology (MT), ASQ Certified Manager of Quality/Organizational Excellence, ASQ Quality Auditor, Six Sigma Black Belt, and Capability Maturity Model Integration (CMMI). He is a licensed Professional Engineer and a US Air Force veteran.
Larry Sampson
Senior Director of Medical Device Processes, Siemens Digital Industries Software
With 20-years of operational experience in Medical Device, Larry Sampson knows firsthand how to balance device development agility and regulatory considerations. As a Sr. Director of Medical Device Processes at Siemens, Larry spends his days educating medical device manufacturers on best practices in all aspects of their product lifecycles. Outside the 9-5, Larry enjoys the great outdoors of Colorado with his family.
Bonjour Bob (sera remplacé par le nom réel pendant la visite du site Web)
Nous voulons en savoir plus sur vous.
Un problème est survenu lors de l'envoi du formulaire. Veuillez réessayer.
C'est votre première souscription aux e-mails en provenance de Siemens Digital Industries Software ? Vous allez bientôt recevoir un e-mail qui vous permettra de confirmer votre inscription.
Bonjour Bob (sera remplacé par le nom réel pendant la visite du site Web)
Vous avez accès à ce séminaire pendant 90 jours. Cliquez ci-dessous pour commencer à regarder.
How to weave a digital thread that advances patient safety
Watch this webinar to learn how, in response to the COVID-19 pandemic, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) collaborated with Siemens Digital Industries Software to explore the application of advanced digital design and manufacturing technologies to improve production agility and resume safe manufacturing operations.
This presentation will feature several use cases and emphasize how a digital thread approach has the potential to transform the way manufacturers design and manufacture medical devices, and how they interact with regulatory agencies.
Daniel Walter
Case for Quality Project Lead, US Food and Drug Administration
Daniel Walter is a member of the compliance and quality staff in the FDA’s Office of Product Evaluation and Quality’s Immediate Office of the Center for Devices and Radiological Health (CDRH). He is currently the Project Lead for Case for Quality, which is an ongoing strategic priority for CDRH, aimed at improving patient access and outcomes, and medical device quality. His background includes being a compliance officer in the CDRH’s Office of Compliance’s Vascular and Circulatory Support Branch; chief of the Foreign Enforcement Branch in the Division of International Compliance Operations overseeing medical device manufacturers; and additional regulatory and industry roles.
Francisco Vicenty
Program Manager, Center for Devices and Radiological Health, US Food and Drug Administration
Francisco (Cisco) Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. This follows roles as branch chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality within the Office of Compliance; as compliance officer in the Cardiac Rhythm and Electrophysiology Branch in CDRH’s Office of Compliance at CDRH; and as a quality and reliability Engineer with IBM’s Micro-Electronics business unit.
Bleta Vuniqi
Team Lead, Quality and Compliance Staff, US Food and Drug Administration
Bleta Vuniqi is a Team Lead within the Quality and Compliance Staff in OPEQ/IO. Bleta has been with the FDA since 2010. Previously, Bleta was the Quality System Specialist within DMQ/OC, and Senior Program Expert in OPEQ/ORP/D1 focusing on PMA policy and process improvement. She previously held a biomedical engineering role within the Respiratory, ENT, General Hospital and Ophthalmic Device Branch in OC where she conducted post market activities regarding these devices and provided regulatory advice in making decisions and resolving regulatory conflicts. Before joining CDRH Bleta was an FDA investigator in ORA responsible for conducting medical device inspections and investigations. She graduated from Wayne State University with a Masters in Biomedical Engineering and Bachelors in Chemistry.
Christopher Brown
Acting Senior Consumer Safety Officer, US Food and Drug Administration
Christopher holds a B.S., and Graduate Certificate in Mechanical Engineering from the University of Maryland, and M.S in Technology Management from University of Maryland University College. He has the following Certifications: Medical Technology (MT), ASQ Certified Manager of Quality/Organizational Excellence, ASQ Quality Auditor, Six Sigma Black Belt, and Capability Maturity Model Integration (CMMI). He is a licensed Professional Engineer and a US Air Force veteran.
Larry Sampson
Senior Director of Medical Device Processes, Siemens Digital Industries Software
With 20-years of operational experience in Medical Device, Larry Sampson knows firsthand how to balance device development agility and regulatory considerations. As a Sr. Director of Medical Device Processes at Siemens, Larry spends his days educating medical device manufacturers on best practices in all aspects of their product lifecycles. Outside the 9-5, Larry enjoys the great outdoors of Colorado with his family.
User event | Registration now open!
Realize LIVE returns in person in 2022, uniting the Siemens global user community around a common mission: To co-create a better world.
Join 3,500+ of your peers to advance innovation, engineer the circular economy, and drive change that’s as sustainable as it is profitable.
Contactez-nous
Support technique produit
Préférences de communication
Bureaux dans le monde