…companies certainly aren’t immune from dupe culture, either. And what is worrying is the damaging impact they could have on human health and behavior. With newly-launched and/or branded medicines commanding…
…companies certainly aren’t immune from dupe culture, either. And what is worrying is the damaging impact they could have on human health and behavior. With newly-launched and/or branded medicines commanding…
…almost 100%. In Japan, examples of CDx reimbursement include the Myriad BRACAnalysis and FoundationOne test. The Myriad test is used for breast, ovarian and several other solid cancers for mutations…
…almost 100%. In Japan, examples of CDx reimbursement include the Myriad BRACAnalysis and FoundationOne test. The Myriad test is used for breast, ovarian and several other solid cancers for mutations…
…a very early stage startup, relying solely on a consultant for regulatory comliance is not the best approach. Generally, companies need in-house Quality and Regulatory people. They may have two…
…a very early stage startup, relying solely on a consultant for regulatory comliance is not the best approach. Generally, companies need in-house Quality and Regulatory people. They may have two…
…role in supporting the company’s clients in all areas of cybersecurity compliance through its services, including: FDA Cybersecurity Filing Readiness Survey: This free assessment for MDMs helps gauge submission readiness…
…role in supporting the company’s clients in all areas of cybersecurity compliance through its services, including: FDA Cybersecurity Filing Readiness Survey: This free assessment for MDMs helps gauge submission readiness…
…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…
…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…
With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…
With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…
…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…
…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…
…barrier (BBB) to elevate the concentration of cell-free DNA (cfDNA) analytes in blood circulation. By increasing analyte concentration, this procedure, called SonoBiopsy, aims to facilitate already validated oncology liquid biopsy…
…barrier (BBB) to elevate the concentration of cell-free DNA (cfDNA) analytes in blood circulation. By increasing analyte concentration, this procedure, called SonoBiopsy, aims to facilitate already validated oncology liquid biopsy…
…FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices to show CM&S credibility. The FDA will…
…FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices to show CM&S credibility. The FDA will…
…usher in a new paradigm of empowerment and compassion in mental healthcare. References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/ …
…usher in a new paradigm of empowerment and compassion in mental healthcare. References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/ …
