Software As Device - Frank Maxwell
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1. The document analyzes how software would be classified under the EU Medical Device Directive and the US Medical Device Data Systems regulation by applying them to a private hospital's software catalog. 2. There are significant differences in how software would be classified under each regulation. The EU regulation considers more software to be medical devices than the US regulation. 3. If bespoke healthcare IT is developed, the hospital could be considered a medical device manufacturer under the EU regulation but not necessarily under the US regulation. 4. Further research is needed on how complementary standards and guidelines could apply, how software evaluation and vendor selection may differ between public and private institutions, and how regulations apply to software in general practitioner offices.
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The FDA Guidance Documents to be discussed:
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019
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This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
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http://semoegy.com
EU Medical Device Directive Newcastle May
HANDIHealth is developing apps to transform healthcare using an app-based model. The presentation discusses how the European Medical Device Directive (MDD) may apply to medical apps. It notes that apps influencing clinical decisions or therapy should be considered medical devices. Key requirements for medical devices include clinical safety risk analysis, quality management systems, and post-market surveillance. The intended use and ability to analyze data to generate new information help determine if software meets the definition of a medical device. Manufacturers of apps deemed medical devices must comply with the MDD.
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When Medical Device Software Fails Due to Improper Verification & Validation ...Sterling Medical Devices
Verification and validation are critical components in the development life cycle of any software and the results of the V & V process are imperative to the safety of the medical device.Software design for_medical_devices_europe_conferent_19012011[1]
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Medical software – us regulation
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Similar to Software As Device - Frank Maxwell
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Regulation
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Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
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European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturer’s fall under the purview of the regulatory framework, which is established to
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Presentation by Bethany Hills, Partner, Mintz Levin: Digital Health Regulation and the FDA. Includes overview of the 21st Century Cures Act, Definition of a medical device, device approval basics, software as a Medical Device (SaMD), FDA Digital Health Activities, mobile medical applications, regulated mobile medical applications, Enforcement discretions of MMA, Clinical Decision Support, 3060 Clarifying Health Software Regulation, Classification Process,
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Connected healthcare innovation is driving the development of new ways to deliver healthcare through the convergence of information technologies and medical devices. International organizations like ISO, Continua, and IHE are establishing interoperability standards to ensure connected devices and electronic health records can securely exchange information. Regulators like the FDA are working to develop guidance that balances innovation while ensuring safety, such as the proposed Medical Device Data System Rule to reclassify certain connected healthcare software. However, regulatory frameworks are still evolving and require further clarification and consensus among stakeholders to adequately oversee new connected healthcare technologies and give assurances about patient safety.
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The European Medicines Agency has observed several challenges in the first year of implementing the Medical Device Regulation for drug-device combination products. Issues include inconsistent device classification, clarifying economic operator roles, and determining what constitutes a substantial device change requiring a new notified body opinion. The EMA is working to address these challenges through ongoing dialogue and plans to update guidance on the regulation.
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Recent FDA Developments in Digital Health & Clinical Decision Support Software
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
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Raising The Level Of ICT Knowledge and Skills In The HSC - Paul Comac
Raising The Level Of ICT Knowledge and Skills In The HSC - Paul Comac
Professional Development Of Health Informatics In Northern Ireland - Paul Mc ...
Professional Development Of Health Informatics In Northern Ireland - Paul Mc ...
Multidisciplinary Team Experience In The Incorporation Of Pacs And Realtime E...
Multidisciplinary Team Experience In The Incorporation Of Pacs And Realtime E...
Making Sense Of Ubiquitous Health Information A Cross Generational Study - Ka...
Making Sense Of Ubiquitous Health Information A Cross Generational Study - Ka...
Lessons Learnt From The Evaluation Of Reminding Aids - Chris Nugent
Lessons Learnt From The Evaluation Of Reminding Aids - Chris Nugent
Issues And Challenges Of Connected Health A Clinical Perspective - Albert Alonso
Issues And Challenges Of Connected Health A Clinical Perspective - Albert Alonso
Integrating Mobile Phones In Wearable Robots - Muthukumaran Thangaramanujam
Integrating Mobile Phones In Wearable Robots - Muthukumaran Thangaramanujam
Innovative Technologies In Community Care - Allan Turner
Innovative Technologies In Community Care - Allan Turner
Software As Device - Frank Maxwell
- 1. Software as a Device The application of the EU-Medical Device Directive and the US-Medical Device Data Systems regulation to a private hospitals software catalog.
- 6. Point of Change - US FDA Centre for Devices and Radiological Health made the clear statement ; “ Under the Federal Food and Drug Cosmetic Act, Healthcare Information Technology software is a medical device” 25 th February 2010 Dr. Jeffery Shuran Director
- 7. Point of Change - EU In May 2010 the UK agency Medical and Health related Regulatory Agency (MHRA) reviewed all incidents where were reported and concludes as software related issues. Table 1: Percentage of reported incidents reported as software issues.
- 11. Medical Devices Directive 93/42/EEC (EU-MDD) “ medical device’ means any instrument, apparatus, appliance, software , material or other article, whether used alone or in combination , including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose
- 13. Application: EU-MDD Decision diagram. (COCIR, 2010)
- 14. Application: EU-MDD Audit Decision Matrix
- 15. Application: US-MDDS Decision diagram for qualification of software (HIMSS Analytics, 2010)
- 16. Application : US-MDDS Audit Decision Matrix
- 18. Results Summary
- 21. Results US-MDDS