Dec 14, 2023 · <p>You are familiar with the terms &ldquo;intended use&rdquo; and &ldquo;indications for use.&rdquo; But not everyone understands exactly what they mean, how they are different, and how they are used.&nbsp;It&#39;s critical for the successful development, regulatory approval, and reimbursement of your device.</p>

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Oct 23, 2024 · ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The purpose of this article is to reinterpret the risk model in Annex C of ISO 14971 using relational risk analysis (ReRA) to describe a better approach for understanding, analyzing, and managing not ...

Dec 10, 2024 · It looks like things will be heating up in 2025 from a regulatory perspective for the medical device industry. Several rules and regulations have important due dates in 2025 and beyond for which manufacturers should start preparing.

Nov 21, 2024 · <p>Leaders from Ernst &amp; 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>

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.

Oct 10, 2024 · <p>The FDA&rsquo;s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.</p>

Apr 18, 2022 · <p data-pm-slice="1 1 []">Most medical device designers and developers have some familiarity with the FDA&#39;s Q-Submission Program. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner. Follow these 5 steps for speedier time-to-market than your competition.</p>

Nov 19, 2020 · By Edwin Bills, Consultant. Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments received during the voting period in early 2016 on both ISO 14971:2007 (the standard for application of risk management to medical devices) and ISO TR 24971:2013 (the ...

Nov 24, 2021 · <p data-pm-slice="1 1 []">Testing performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the&nbsp;strategic approaches to ...