Crafting Superior Health Software: IEC 82304-1 ComplianceIEC 82304-1:2016 is tailored to health software products designed to operate on general computing platforms without dedicated hardware. It is aimed at products intended for the market and…
Continue Reading
The following is a guest article by Doug Bierbower, Vice President of Solutions Engineering at SOLiD Americas
When delivering first-rate care, every aspect of the patient experience is critical. And in today’s always-connected 5G world,…
Simulation technologies catalyze medical device innovation, mitigating challenges in safety, efficacy, and market delivery. Erik Johnson underscores their pivotal role in ensuring patient safety, testing usability, and bolstering cybersecurity. By streamlining design validation and…
Continue Reading
ISO 14971 is a pivotal standard for risk management in the design and production of medical devices, emphasizing the importance of assessing and controlling risks throughout a product’s lifecycle. Here’s an in-depth look at…
Continue Reading
Background: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial…
Continue Reading
Fresh off a Digital Health Hub award at the HLTH annual conference in Las Vegas in October, AI dermatology company Skin Analytics is aiming to build on its position as the only holder of…
Continue Reading
The Scope of ISO 13485Lifecycle Coverage: The standard encompasses all stages of a medical device’s lifecycle, from design to post-production, ensuring quality and safety at every phase.Auditing Utility: It is also utilized by certification…
Continue Reading
Are you a digital health entrepreneur looking to navigate the complex landscape of ISO certifications? Our latest video illustrates the world of ISO and standardization regulations, providing you with the essential roadmap to elevate…
Continue Reading
What You Should Know:
– A new critical vulnerability was discovered in NeuroWorks Natus Electroencephalogram (EEG) Software that could allow cybercriminals to take control of affected devices and steal medical data. NeuroWorks Natus Electroencephalogram (EEG)…
Continue Reading
Collaboration among stakeholders in India could be the key to promoting further the development of quality, high-end medical devices that can pinpoint and address patient needs and offer sustainability.KPMG in India, together with the Asia Pacific Medical…
Continue Reading
