Key Considerations In "Intended Use" And "Indications For Use ...
Dec 14, 2023 · <p>You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.</p>
Understanding The New MHRA Requirements For Medical Devices …
Apr 9, 2024 · Recent developments at U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) as a result of EU MDR extensions and other factors have caused the agency to update its transition arrangement dates for CE marked devices.
Med Device Online: Advancing human health by connecting …
In early December, the FDA issued final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled device software functions. This article shares the 13 key takeaways, including differences from the draft guidance.
Adaptive AI-Driven Medical Devices In The US Ethical Considerations
Oct 28, 2024 · <p>With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an additional layer of complexity to design and development.</p>
We're Heading Toward A Bottleneck For EU MDR Approvals How …
Nov 13, 2024 · The deadline for medical devices compliance to the new medical devices regulation 2017/745 (EU MDR) was originally May 2020 for class l non-sterile devices and May 2024 for all other devices. During those first years, the accreditation of notified bodies to EU MDR was a lengthy process, which was further slowed down by the pandemic.
Medtech: Capitalize On These 4 Trends To Thrive In 2025
Nov 21, 2024 · <p>Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy medtech companies will seize for success in 2025.</p>
Understanding The FDAs New Medical Device Cybersecurity …
Nov 20, 2023 · <p>The FDA cybersecurity requirements for medical “cyber devices” went into effect on Oct. 1, 2023. The FDA has made it clear that it cannot even accept submissions that don’t contain the cybersecurity requirements. This article shares 4 steps to navigate the new requirements.</p>
FDA Releases Guidance On Cybersecurity In Medical Devices
May 31, 2022 · <p>The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).</p>
AI-enabled Medical Devices In India Opportunities And Challenges
May 7, 2024 · The medical device market in India is one of the best places for the world to tap into since the early 2000s.Many are watching the evolution of the medical device industry in India, with McKinsey and Co. predicting that competition in the medical device space will follow a trend that has occurred in other industries: multinational corporations (MNCs) establish the market, followed by …
AI-Enabled Medical Device Manufacturers Are You Prepared for …
Nov 1, 2024 · With the rise AI-enabled medical devices, the FDA is soliciting comments and feedback regarding the importance of AI safety and effectiveness considerations in advance of its upcoming Digital Health Advisory Committee Meeting.The meeting will specifically address FDA concerns related to total product life cycle considerations for generative artificial intelligence (AI)-enabled devices ...