…market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from the extended transition period….
…market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from the extended transition period….
…of the design. For example, if redesigning an existing product, the new GUI should consider maintaining some legacy elements while addressing any current challenges and new elements. Designers also need…
…of the design. For example, if redesigning an existing product, the new GUI should consider maintaining some legacy elements while addressing any current challenges and new elements. Designers also need…
…will interrelate. FDA won’t decide these questions alone. Rather, a public-comment period follows publication of the draft guidance, in which stakeholders can speak to how FDA should conduct remote device…
…will interrelate. FDA won’t decide these questions alone. Rather, a public-comment period follows publication of the draft guidance, in which stakeholders can speak to how FDA should conduct remote device…
…and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health…
…and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health…
…priorities, especially when it comes to budget considerations, and both national and privately owned medical facilities are finding that Unified Communications (UC) can play a key role in improving both…
…priorities, especially when it comes to budget considerations, and both national and privately owned medical facilities are finding that Unified Communications (UC) can play a key role in improving both…
…under the new regulation. Is that due to a lack of clarity in the regulation or a lack of notified bodies or a combination of factors? Wreh: It is both….
…under the new regulation. Is that due to a lack of clarity in the regulation or a lack of notified bodies or a combination of factors? Wreh: It is both….
…e-labeling makes externally facing product information more dynamic and immediately accessible online or through an app. This information can be provided as a downloadable document, a shorter-form searchable text, or…
…e-labeling makes externally facing product information more dynamic and immediately accessible online or through an app. This information can be provided as a downloadable document, a shorter-form searchable text, or…
…company. To remain viable in this heavily competitive market, SMEs often don’t have the funds to invest deeply in cybersecurity staff or to ask the right questions about what is…
…company. To remain viable in this heavily competitive market, SMEs often don’t have the funds to invest deeply in cybersecurity staff or to ask the right questions about what is…
…the “Core Pillars” of a comprehensive legacy technology cyber risk management program, including: Governance: How should healthcare stakeholders govern to ensure effective legacy technology cyber risk management? Communications: How should…
…the “Core Pillars” of a comprehensive legacy technology cyber risk management program, including: Governance: How should healthcare stakeholders govern to ensure effective legacy technology cyber risk management? Communications: How should…
…a patient, oversight becomes more challenging. As we enter the relatively new territory of 3DPOC devices, it will be interesting to see how regulators, providers and manufacturers come together to…
…a patient, oversight becomes more challenging. As we enter the relatively new territory of 3DPOC devices, it will be interesting to see how regulators, providers and manufacturers come together to…
