Mahdi Abbasi
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FDA Seeks Input on At-Home Use Medical Technologies
…communities. In particular, CDRH seeks comment from the industry and the public on the following questions: How can the FDA support the development of medical technologies, including digital health technologies…
…communities. In particular, CDRH seeks comment from the industry and the public on the following questions: How can the FDA support the development of medical technologies, including digital health technologies…
Mitigating Supply Chain Risks
…a Global Supply Chain Hugo Felix This session will address risk management execution for combination products and the challenge when regulators don’t define combination products consistently across the world and…
…a Global Supply Chain Hugo Felix This session will address risk management execution for combination products and the challenge when regulators don’t define combination products consistently across the world and…
Final Guidance for Submission of Off-The-Shelf Software in Medical Devices
…OTS Software to address each of the following questions: What is it? What are the Computer System Specifications for the OTS Software? How will you assure appropriate actions are taken…
…OTS Software to address each of the following questions: What is it? What are the Computer System Specifications for the OTS Software? How will you assure appropriate actions are taken…
MedTech Marketing Pearls for FDA Clearance and Beyond
…your product’s unique advantages in a personal way that differentiates it from all others. Capturing the compelling essence of a new product can make all the difference in getting people…
…your product’s unique advantages in a personal way that differentiates it from all others. Capturing the compelling essence of a new product can make all the difference in getting people…
Amanda Bloom
Bringing More Patients Home
…care model. We are consistently finding new types of procedures where we can potentially discharge the patient the same day. For example, transcatheter aortic valve replacement (TAVR), where instead of…
…care model. We are consistently finding new types of procedures where we can potentially discharge the patient the same day. For example, transcatheter aortic valve replacement (TAVR), where instead of…
FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity
…is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET. During the event, drug sponsors, medical device sponsors, clinical research organizations, academia, patients and other stakeholders…
…is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET. During the event, drug sponsors, medical device sponsors, clinical research organizations, academia, patients and other stakeholders…
The Underrated Variable of IoMT Device Security: Collaboration
…study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare Data Breach Increases to Almost $11 Million,” The HIPAA Journal, July 24, 2023, https://www.hipaajournal.com/2023-cost-healthcare-data-breach/…
…study finds,” Healthcare Dive, September 8, 2023, https://www.healthcaredive.com/news/cyberattacks-hospitals-disrupt-operations-patient-care-Ponemon/631439/ [ii] [ii] “IBM: Average Cost of a Healthcare Data Breach Increases to Almost $11 Million,” The HIPAA Journal, July 24, 2023, https://www.hipaajournal.com/2023-cost-healthcare-data-breach/…
Itâs Time for MedTech to Recognize PFAS Urgency
…in the Stockholm Convention. https://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx [3] Health and Safety Executive. (2023, March). Analysis of the most appropriate regulatory management options (RMOA). https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf [4] 3M. (n.d.). PFAS & Their Uses. https://pfas.3m.com/pfas_uses…
…in the Stockholm Convention. https://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx [3] Health and Safety Executive. (2023, March). Analysis of the most appropriate regulatory management options (RMOA). https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf [4] 3M. (n.d.). PFAS & Their Uses. https://pfas.3m.com/pfas_uses…
