Healthcare leaders today face the complicated test of transforming existing systems to create a social and natural environment in which our patient’s and communities’ wellbeing can thrive, while improving health…
Healthcare leaders today face the complicated test of transforming existing systems to create a social and natural environment in which our patient’s and communities’ wellbeing can thrive, while improving health…
…be spending their time updating the plan and communicating with their engineering teams and other stakeholders to keep their team coordinated. Avoid these common pitfalls and follow a few best…
…be spending their time updating the plan and communicating with their engineering teams and other stakeholders to keep their team coordinated. Avoid these common pitfalls and follow a few best…
…or vendors can thus draw helpful examples and information for their product development from the standard itself. And the support provided by testing, inspection and certification (TIC) companies specializing in…
…or vendors can thus draw helpful examples and information for their product development from the standard itself. And the support provided by testing, inspection and certification (TIC) companies specializing in…
…for better patient oversight by providing site partners with an accessible, secure, and comprehensive view of a patient’s health during a trial, allowing more timely management of task completion, remote…
…for better patient oversight by providing site partners with an accessible, secure, and comprehensive view of a patient’s health during a trial, allowing more timely management of task completion, remote…
…years Products getting increasingly complex Paper-based or disconnected risk management processes Changes to regulatory requirements, namely the latest updates to Medical Device Single Audit Program (MDSAP) adopted by regulators in…
…years Products getting increasingly complex Paper-based or disconnected risk management processes Changes to regulatory requirements, namely the latest updates to Medical Device Single Audit Program (MDSAP) adopted by regulators in…
…artificial intelligence (AI) capabilities. Assistive listening devices are also boosting the efficacy of hearing aids by filtering through background noise, particularly in crowded areas. Some common types of assistive listening…
…artificial intelligence (AI) capabilities. Assistive listening devices are also boosting the efficacy of hearing aids by filtering through background noise, particularly in crowded areas. Some common types of assistive listening…
…information, including email address Premarket authorization numbers (for example, premarket approval application or 510(k) number) for all devices for which the exemption is requested Copy of any relevant FDA premarket…
…information, including email address Premarket authorization numbers (for example, premarket approval application or 510(k) number) for all devices for which the exemption is requested Copy of any relevant FDA premarket…
…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…
…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…
…is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized. “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” proposes…
…is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized. “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” proposes…
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with…
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with…
